Instrument, Biopsy
FDA product code KNW · Class II (moderate risk) · 21 CFR 876.1075 · Gastroenterology, Urology
365510(k) clearances
0PMA approvals
96recalls
Manufacturers
- Medical Device Technologies, Inc. 15
- C.R. Bard, Inc. 11
- Gallini U.S., LLC 10
- Manan Medical Products, Inc. 10
- Ranfac, Corp. 9
- Daum Corp. 9
- Senorx, Inc. 9
- Inrad 8
- Bard Peripheral Vascular Inc 8
- Devicor Medical Products, Inc. 7
- Manan Manufacturing Co., Inc. 7
- Ethicon Endo-Surgery, Inc. 7
- Sanarus Medical, Inc. 6
- Biopsys Medical, Inc. 6
- Stryker Corporation 5
- Medax Srl Unipersonale 5
- Promex, Inc. 5
- Remington Medical, Inc. 4
- Gallini Intl., Inc. 4
- Baxter Healthcare Corp 4
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260517 | Automatic Core Biopsy InstrumentKNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 08/28/2026SE |
| K262571 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Special | Bard Peripheral Vascular, Inc. | 08/14/2026SE |
| K262792 | Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)KNW · Special | Hologic, Inc. | 08/12/2026SE |
| K260572 | Marrow MarxmanKNW · Traditional | Medimetrix, LLC | 08/04/2026SE |
| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | Promisemed Hangzhou Meditech Co., Ltd. | 05/12/2026SE |
| K260365 | Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome…KNW · Traditional | Devicor Medical Products, Inc. | 03/04/2026SE |
| K252795 | ZeniCore Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga…KNW · Traditional | Argon Medical Devices, Inc. | 02/23/2026SE |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal SystemKNW · Traditional | Bard Peripheral Vascular, Inc. | 12/12/2025SE |
| K252183 | Resitu Slider 09 (RESL09)KNW · Traditional | Resitu Medical AB | 09/24/2025SE |
| K243407 | Forcyte Autograft Harvest KitKNW · Traditional | Forcyte Medical, LLC | 07/29/2025SE |
| K244018 | Disposable Biopsy NeedleKNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 07/22/2025SE |
| K243296 | Disposable Biopsy NeedleKNW · Traditional | Carbon (Shenzhen) Medical Device Co., Ltd. | 07/11/2025SE |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument KitKNW · Special | Bard Peripheral Vascular, Inc. | 07/10/2025SE |
| K243886 | ExpressCore Biopsy DeviceKNW · Traditional | Inrad, Inc. | 04/29/2025SE |
| K243945 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW · Traditional | SurGenTec, LLC | 04/24/2025SE |
| K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…KNW · Traditional | Xaga Surgical | 02/27/2025SE |
| K242322 | Bone Marrow Biopsy NeedleKNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 01/24/2025SE |
| K241793 | Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable…KNW · Traditional | Zhejiang Curaway Medical Technology Co., Ltd. | 01/24/2025SE |
| K242228 | Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle…KNW · Traditional | Triopsy Medical, Inc. | 01/10/2025SE |
| K243095 | Mammotome AutoCore Single Insertion Core Biopsy SystemKNW · Traditional | Devicor Medical Products, Inc. | 10/29/2024SE |
| K242029 | Trap EasyKNW · Traditional | H.S Hospital Service S.P.A | 10/09/2024SE |
| K240664 | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)KNW · Traditional | SurGenTec, LLC | 08/09/2024SE |
| K233294 | Automatic Biopsy Needle BAM, Semi-Automatic Needle BIMKNW · Traditional | Itp Innovative Tomography Products GmbH | 06/18/2024SE |
| K233031 | M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic…KNW · Traditional | Canyon Medical, Inc. | 01/17/2024SE |
| K230646 | SUREcore Prime Biopsy InstrumentKNW · Traditional | Uro-1 Medical, Inc. | 11/29/2023SE |
| K233220 | EnCor EnspireBreast Biopsy System (E4115, E4230); EnCor Breast Biopsy Driver…KNW · Special | Senorx, Inc. | 10/27/2023SE |
| K230015 | OmniBone Bone Marrow Biopsy Kit with Power Driver, OmniBone Bone Biopsy Kit with Power…KNW · Traditional | Laurane Medical Sas | 06/16/2023SE |
| K223300 | Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M…KNW · Traditional | Geotek Medikal Ltd Sti | 04/21/2023SE |
| K222865 | M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic…KNW · Traditional | Canyon Medical, Inc. | 04/03/2023SE |
| K223612 | Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)KNW · Special | Ranfac Corporation | 02/21/2023SE |
| K222462 | Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15)…KNW · Traditional | Itp Innovative Tomography Products GmbH | 01/20/2023SE |
| K220611 | SUREcore Plus Biopsy InstrumentKNW · Traditional | Uro-1, Inc. | 12/02/2022SE |
| K220595 | NeoNavia Biopsy SystemKNW · Traditional | Neodynamics AB | 09/08/2022SE |
| K212820 | Disposable Semi Automatic Biopsy InstrumentKNW · Traditional | Suzhou Leapmed Healthcare Corporation | 07/06/2022SE |
| K213232 | NovaCore Semi-Automatic Biopsy InstrumentKNW · Traditional | Argon Medical Devices | 07/01/2022SE |
| K214063 | Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131…KNW · Traditional | Guangzhou Shengwei Medical Devices Co., Ltd. | 06/03/2022SE |
| K213683 | Promisemed Fine Biopsy NeedleKNW · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 04/22/2022SE |
| K213896 | BD Trek Powered Bone Biopsy SystemKNW · Traditional | Bard Peripheral Vascular | 03/30/2022SE |
| K212079 | TeesuVac Breast Biopsy Device Mark 1KNW · Traditional | Teesuvac Aps | 02/02/2022SE |
| K213213 | Arthrex Vortex Threaded Bone Marrow Recovery NeedleKNW · Traditional | Arthrex, Inc. | 11/19/2021SE |
| K212284 | Disposable Automatic Core Biopsy InstrumentKNW · Traditional | Suzhou Leapmed Healthcare Corporation | 11/10/2021SE |
| K203141 | Uramix CuraWay Biopsy NeedleKNW · Traditional | Uramix, Inc. | 09/17/2021SE |
| K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed…KNW · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 08/12/2021SE |
| K211933 | EleVation Breast Biopsy SystemKNW · Special | Bard Peripheral Vascular | 07/15/2021SE |
| K210654 | EnCor Breast Biopsy Probe with Rinse TubeKNW · Special | Senorx, Inc. | 03/31/2021SE |
| K210631 | Avitus(r) Bone HarvesterKNW · Special | Avitus Orthopaedics, Inc. | 03/31/2021SE |
| K201650 | VMCore Biopsy NeedleKNW · Traditional | Uro-1, Inc. | 01/15/2021SE |
| K203397 | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or…KNW · Traditional | Biopsybell S.R.L. | 01/11/2021SE |
| K202287 | Ran-Flex-B Bone Marrow Aspiration NeedleKNW · Traditional | Ranfac Corporation | 09/18/2020SE |
| K201166 | Temno Elite Biopsy SystemKNW · Traditional | Merit Medical Systems, Inc. | 08/28/2020SE |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) SystemKNW · Traditional | Devicor Medical Products, Inc. | 08/18/2020SE |
| K201244 | Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy DevicesKNW · Special | Transmed7, LLC | 08/07/2020SE |
| K192101 | Medone Ultra, MedextraKNW · Traditional | Medax Srl Unipersonale | 04/02/2020SE |
| K192099 | MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…KNW · Traditional | Medax Srl Unipersonale | 04/02/2020SE |
| K200278 | CytoCoreKNW · Traditional | Praxis Medical, LLC | 03/31/2020SE |
| K193268 | APrioCore PlusKNW · Traditional | Apriomed AB | 02/27/2020SE |
| K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast…KNW · Special | Bard Peripheral Vascular, Inc. | 11/07/2019SE |
| K191315 | Remington Medical, Inc. Automatic Cutting Needle (NAC)KNW · Traditional | Remington Medical, Inc. | 07/12/2019SE |
| K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,KNW · Special | Ranfac Corporation | 06/12/2019SE |
| K190378 | Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome…KNW · Traditional | Bioncise NV | 05/24/2019SE |
| K183146 | Ranfac Cartilage Biopsy NeedleKNW · Traditional | Ranfac Corporation | 04/25/2019SE |
| K181803 | Medax Biopsy Systems IIIKNW · Traditional | Medax Srl Unipersonale | 10/18/2018SE |
| K171890 | BEXCORE Breast Biopsy System, Biopsy NeedleKNW · Traditional | Medical Park Co., Ltd. | 08/20/2018SE |
| K173316 | SpeedBird Model SB38 Soft Tissue Biopsy Device; SpeedBird Model SBU Soft Tissue Biopsy…KNW · Traditional | Transmed7, LLC | 06/19/2018SE |
| K180807 | Celling Aspiration NeedleKNW · Traditional | Spine Smith Holdings, LLC | 05/24/2018SE |
| K180233 | Eviva Stereotactic Guided Breast Biopsy SystemKNW · Traditional | Hologic, Inc. | 04/10/2018SE |
| K180450 | Corvocet Biopsy SystemKNW · Special | Merit Medical Systems, Inc. | 03/12/2018SE |
| K180327 | Stryker iVAS 13g Bone Biopsy KitKNW · Special | Stryker Corporation | 02/26/2018SE |
| K172344 | Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)KNW · Traditional | Medax Srl Unipersonale | 11/13/2017SE |
| K172558 | iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy KitKNW · Traditional | Stryker Corporation | 10/05/2017SE |
| K171953 | Bard Mission Disposable Core Biopsy InstrumentKNW · Traditional | Bard Peripheral Vascular, Inc. | 09/14/2017SE |
| K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…KNW · Traditional | Care Fusion | 09/11/2017SE |
| K162588 | Möller Medical Biopsy Needles and SystemsKNW · Traditional | Moller Medical GmbH | 06/19/2017SE |
| K163052 | Brevera Biopsy System with Corlumina Imaging TechnologyKNW · Traditional | Hologic, Inc. | 03/29/2017SE |
| K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone…KNW · Special | Avitus Orthopaedics, Inc. | 03/20/2017SE |
| K170008 | Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle SetKNW · Traditional | Cook Incorporated | 02/28/2017SE |
| K160316 | SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…KNW · Traditional | M.D.L. S.R.L. | 10/27/2016SE |
| K153709 | Mammotome elite Biopsy System-13G Probe, Mammotome elite Biopsy System-10G Probe…KNW · Traditional | Devicor Medical Products, Inc. | 08/08/2016SE |
| K161234 | CASSI II Rotational Core Biopsy SystemKNW · Special | Scion Medical Technologies, LLC | 08/03/2016SE |
| K161409 | M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemKNW · Traditional | Mermaid Medical A/S | 08/02/2016SE |
| K161805 | EnCor MRI Introducer Set, EnCor Probe IntroducerKNW · Special | Senorx, Inc. | 07/19/2016SE |
| K153337 | Corvocet Biopsy SystemKNW · Traditional | Merit Medical Systems, Inc. | 03/25/2016SE |
| K152989 | Mammotome revolve Dual Vacuum Assist Biopsy SystemKNW · Traditional | Devicor Medical Products, Inc. | 02/25/2016SE |
| K152596 | Intact® Gen2 SystemKNW · Traditional | Intact Medical Corporation | 02/15/2016SE |
| K152872 | K2M Fenestrated Tap SystemKNW · Traditional | K2m | 01/05/2016SE |
| K142125 | New Medax Biopsy SystemsKNW · Traditional | Medax Srl Unipersonale | 12/22/2015SE |
| K153306 | Imbibe NeedleKNW · Special | Orthovita, Inc. | 12/18/2015SE |
| K152474 | Avitus Bone HarvesterKNW · Traditional | Avitus Orthopaedics, Inc. | 10/23/2015SE |
| K150169 | Sertera Biopsy DeviceKNW · Traditional | Hologic, Inc. | 08/14/2015SE |
| K150088 | Evacore Fully Disposable Vacuum Assist Biopsy DeviceKNW · Traditional | Pin-Point Care Corp. | 07/20/2015SE |
| K150625 | Morrison Steerable NeedleKNW · Traditional | Apriomed AB | 06/09/2015SE |
| K150563 | Marrow Cellution Bone Marrow Aspiration NeedleKNW · Traditional | Ranfac, Corp. | 05/22/2015SE |
| K141910 | Intraosseous Cannula System Bio-MAC¿ and Bio-COREKNW · Traditional | Biologic Therapies, Inc. | 05/04/2015SE |
| K143546 | Imbibe Aspirating XIA TapsKNW · Traditional | Stryker Corporation | 03/19/2015SE |
| K142791 | Spectra Soft Tissue Biopsy NeedlesKNW · Traditional | Spectra Medical Devices | 01/21/2015SE |
| K142377 | The OnControl Bone Marrow Biopsy System by VidacareKNW · Traditional | Vidacare, LLC | 12/17/2014SE |
| K142477 | Intact Advance and Intact Excision XL, Intact BLESKNW · Traditional | Intact Medical Corporation | 12/15/2014SE |
| K140991 | Ranfac Aspiration Needle with Adjustable GuideKNW · Traditional | Ranfac, Corp. | 09/11/2014SE |
| K141552 | Achieve Programmable Auomated Biopsy SystemsKNW · Traditional | Care Fusion | 09/05/2014SE |
| K141673 | Ivas 8 Gauge Bone Biopsy KitKNW · Special | Stryker Corporation | 09/04/2014SE |
| K133702 | Presto Breast Biopsy DeviceKNW · Special | Sontina Medical, LLC | 02/28/2014SE |
| K133948 | Bard(R) Monopty(R) Disposable Core Biopsy Instrument, Bard(R) Max-Core(R) Disposable…KNW · Special | Bard Peripheral Vascular, Inc. | 02/21/2014SE |
| K130616 | Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-NeedlesKNW · Traditional | Biopsybell S.R.L. | 02/07/2014SE |
| K131157 | Ranfac Bone Marrow Aspiration NeedleKNW · Traditional | Ranfac, Corp. | 10/22/2013SE |
| K130282 | Remington Medical Centrefire 22 Biopsy InstrumentKNW · Traditional | Remington Medical, Inc. | 05/13/2013SE |
| K123606 | Cassi II Rotational Core Biopsy System; Cassi Quadpoint DisposableKNW · Special | Scion Medical Technologies, LLC | 03/01/2013SE |
| K123259 | Mammotome Reolve Dual Vacuum Assisted Biopsy (Vab) SystemKNW · Traditional | Devicor Medical Products, Inc. | 11/15/2012SE |
| K121181 | Swannshidi Bone Marrow Aspiration NeedleKNW · Traditional | Alliance Partners, LLC | 08/22/2012SE |
| K120002 | I-Style Bone Marrow Aspiration Needle with T-HandleKNW · Traditional | Busse Hospital Disposables, Inc. | 06/26/2012SE |
| K120440 | Presto Breast Biopsy DeviceKNW · Traditional | Sontina Medical, LLC | 05/17/2012SE |
| K112411 | Mammotome Elite Biopsy SystemKNW · Traditional | Devicor Medical Products, Inc. | 03/20/2012SE |
| K113872 | The Oncontrol Bone Access and Bone Biopsy System by VidacareKNW · Traditional | Vidacare Corporation | 03/08/2012SE |
| K120189 | BonetrapKNW · Traditional | Berni Farns Incorporated | 02/22/2012SE |
| K102756 | Surecore Biopsy DeviceKNW · Traditional | Chest Innovations, Inc. | 11/29/2011SE |
| K113209 | Chiba SonoKNW · Traditional | Pajunk GmbH | 11/21/2011SE |
| K112945 | Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, With/Hilitier 18GAX10CM…KNW · Special | Inrad, Inc. | 11/03/2011SE |
| K112468 | The Oncontrol Bone Access System by VidacareKNW · Traditional | Regulatory Specialists, Inc. | 10/20/2011SE |
| K111765 | Full Core Biopsy SystemKNW · Traditional | Promex Technologies, LLC | 09/06/2011SE |
| K111529 | Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model RP-1820, MCN Core…KNW · Traditional | Insert Molding Solutions, Inc. | 07/29/2011SE |
| K102771 | Biopsy Handy, MRI Biopsy HandyKNW · Traditional | Somatex Medical Technologies GmbH | 06/24/2011SE |
| K111100 | Encor Enspire Breast Biopsy SystemKNW · Special | C.R. Bard, Inc. | 06/16/2011SE |
| K110883 | J-Style Bone Marrow Biopsy / Aspiration Needle with Snare-It Marrow Acquisition CannulaKNW · Traditional | Busse Hospital Disposables | 06/08/2011SE |
| K092338 | Medax Unipersonale SRLKNW · Traditional | Medax Unipersonale Srl | 05/27/2011SE |
| K103359 | Finesse Ultra Breast Biopsy System Driver (Blue, Pink)KNW · Special | C.R. Bard, Inc. | 12/27/2010SE |
| K101832 | Biopince Ultra Full Core Biopsy InstrumentKNW · Traditional | Medical Device Technologies, Inc. | 08/27/2010SE |
| K093899 | Mammotome Biopsy System for Molecular ImagingKNW · Traditional | Ethicon Endo-Surgery, LLC | 04/29/2010SE |
| K093512 | Encor Breast Biopsy SystemKNW · Traditional | Senorx, Inc. | 11/20/2009SE |
| K093399 | Precisecore 10 MM Biopsy Device- 14GA X 5 CM Model 670514, 671014, 670518 671018, 670520KNW · Traditional | Inrad | 11/19/2009SE |
| K093256 | Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018KNW · Traditional | Inrad | 11/17/2009SE |
| K093068 | Finesse Ultra Breast Biospy System Driver - Blue, Pink, Probe FO1BLU, Foipnk, F14105USKNW · Traditional | C.R. Bard, Inc. | 11/10/2009SE |
| K092059 | RP Cutting NeedleKNW · Traditional | Riverpoint Medical | 09/24/2009SE |
| K090611 | Revolution Full Core BiopsyKNW · Traditional | Inrad | 06/04/2009SE |
| K082681 | Vacora Vacuum Assisted Biopsy SystemKNW · Special | C.R. Bard, Inc. | 10/15/2008SE |
| K081057 | Intact Breast Lesion Excision System with Intact Excision XLKNW · Traditional | Intact Medical Corporation | 06/17/2008SE |
| K080095 | Coramate/Spirotome SystemKNW · Traditional | Medinvents | 04/11/2008SE |
| K080171 | Sanarus Incore Rotational Core Biopsy Device, Models CB3010, CB3012KNW · Traditional | Sanarus Medical, Inc. | 03/06/2008SE |
| K072045 | Oncontrol Bone Marrow Biopsy SystemKNW · Traditional | Vidacare Corporation | 10/22/2007SE |
| K071814 | Light Sabre Spinal Access DeviceKNW · Traditional | Minrad, Inc. | 10/16/2007SE |
| K071048 | Rubicor Magic Breast Biopsy Device, Model 31537KNW · Special | Rubicor Medical, Inc. | 05/15/2007SE |
| K063233 | Deltacut (Apparatus and Cannula)KNW · Traditional | PAJUNK GmbH Medizintechnologie | 04/30/2007SE |
| K070091 | Coaxial Bone and Vertebral Body Biopsy Needle Model# JBC1213, JBC1208KNW · Traditional | Cardinal Health, Inc. | 04/18/2007SE |
| K063697 | Special Sprotte, Chiba, DR Steinhoff KitKNW · Traditional | PAJUNK GmbH Medizintechnologie | 02/14/2007SE |
| K062832 | Vacora 14G Biopsy Probes, Models VB14116, VB14138KNW · Special | C.R. Bard, Inc. | 10/20/2006SE |
| K060384 | Coramate/Spirotome SystemKNW · Traditional | Medinvents | 07/13/2006SE |
| K061570 | I-Style Bone Marrow Aspiration NeedleKNW · Traditional | Busse Hospital Disposables, Inc. | 07/03/2006SE |
| K060413 | Intact Breast Lesion Excision System and AdvanceKNW · Traditional | Intact Medical Corporation | 04/27/2006SE |
| K053151 | Rubicor Magic Breast Biopsy DeviceKNW · Traditional | Rubicor Medical, Inc. | 11/18/2005SE |
| K052638 | Abbott Spine, Inc. Spinnaker SystemKNW · Traditional | Abbott Spine, Inc. | 11/07/2005SE |
| K052435 | Pneumrx Family of Biopsy Needles and KitsKNW · Traditional | Pneumrx, Inc. | 11/03/2005SE |
| K052802 | Manan Bio-Cut Soft Tissue Biopsy NeedleKNW · Special | Manan Medical Products, Inc. | 11/01/2005SE |
| K051581 | Sanarus Cassi II Rotational Core Biopsy System, Model CS2000KNW · Traditional | Sanarus Medical, Inc. | 07/27/2005SE |
| K051361 | Easy Core Detachable Biopsy SystemKNW · Special | Boston Scientific Corp | 06/16/2005SE |
| K050795 | Imbibe Bone Marrow Aspiration NeedleKNW · Traditional | Orthovita, Inc. | 06/03/2005SE |
| K051158 | Encor 7 GaugeKNW · Special | Senorx, Inc. | 05/16/2005SE |
| K043523 | Interv Brand Snarelok Bone Marrow Biopsy NeedleKNW · Traditional | Medical Device Technologies, Inc. | 02/11/2005SE |
| K042753 | Mammotome MR Biopsy SystemKNW · Traditional | Ethicon Endo-Surgery, Inc. | 11/08/2004SE |
| K042290 | Vacuum Assisted Core Biopsy DeviceKNW · Traditional | Suros Surgical Systems, Inc. | 10/06/2004SE |
| K042464 | V-Core Full Core Breast Biopsy InstrumentKNW · Traditional | Medical Device Technologies, Inc. | 09/30/2004SE |
| K042136 | Sanarus Cassi Rotational Core Biopsy SystemKNW · Special | Sanarus Medical, Inc. | 09/08/2004SE |
| K034021 | Vacuum Assisted Core Biopsy DeviceKNW · Traditional | Suros Surgical Systems, Inc. | 09/08/2004SE |
| K041544 | Cook Sidearm Core Tissue Biopsy DeviceKNW · Traditional | Urological, Inc. | 07/22/2004SE |
| K040266 | Core Needle BiopsyKNW · Traditional | Remington Medical, Inc. | 07/09/2004SE |
| K040842 | Senorx Biopsy Device IIKNW · Special | Senorx, Inc. | 04/30/2004SE |
| K040087 | RabbitKNW · Traditional | Scion International, Inc. | 04/01/2004SE |
| K033616 | Trapmatic System SetKNW · Traditional | H.S Hospital Service S.P.A | 03/01/2004SE |
| K033700 | Mammotome Ex Hand Held SystemKNW · Traditional | Ethicon Endo-Surgery, Inc. | 02/20/2004SE |
| K032943 | Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy KitsKNW · Traditional | Stryker Corp. | 12/17/2003SE |
| K033427 | Modification to En-Bloc Biopsy SystemKNW · Special | Neothermia Corp. | 11/10/2003SE |
| K032506 | Sanarus Centrica II Rotational Core Biopsy SystemKNW · Traditional | Sanarus Medical, Inc. | 10/09/2003SE |
| K030472 | Mammotome Biopsy System Probe & Housing, Mammotome Hand-Held SystemKNW · Traditional | Ethicon Endo-Surgery, Inc. | 10/09/2003SE |
| K032847 | Excisor Bioptome, Model 01-0004KNW · Traditional | Acueity, Inc. | 09/26/2003SE |
| K031344 | Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (GSS) NeedleKNW · Traditional | Ranfac, Corp. | 05/23/2003SE |
| K030443 | Mammary Aspiration Specimen Cytology TestKNW · Traditional | Nastech Pharmaceutical Company, Inc. | 05/09/2003SE |
| K024089 | Vacuflash Biopsy SystemKNW · Traditional | Bip USA, Inc. | 03/11/2003SE |
| K023923 | Senocor 360 Circumferential Vacuum Assisted Biopsy Device, 8 GaugeKNW · Special | Senorx, Inc. | 12/11/2002SE |
| K022286 | Encircle Localization DeviceKNW · Traditional | Vivant Medical, Inc. | 10/11/2002SE |
| K022879 | Modification to Sanarus Centrica Core Tissue BiopsyKNW · Special | Sanarus Medical, Inc. | 09/23/2002SE |
| K020848 | Nafd 100KNW · Traditional | Neomatrix, LLC | 09/23/2002SE |
| K021707 | Single Step Biopsy Device, Single Step Surgical Handle, Single Step Driver, Single Step…KNW · Traditional | Senorx, Inc. | 08/14/2002SE |
| K022169 | Clearview Plus Bone and Vertebral Body Biopsy NeedlesKNW · Special | Parallax Medical, Inc. | 07/25/2002SE |
| K021137 | Sanarus Centrica Core Tissue Biopsy SystemKNW · Traditional | Sanarus Medical, Inc. | 06/26/2002SE |
| K020987 | BMN I Type Marrow Aspiration NeedleKNW · Traditional | H.S. Hospital Service S.R.L. | 06/25/2002SE |
| K020867 | Bone Marrow Aspiration Needle, Model BMB1110J, Bone Marrow Harvest Needle, Model…KNW · Traditional | Worldwide Medical Technologies, LLC | 05/20/2002SE |
| K013108 | BiosucKNW · Traditional | Hakko Medical Co., Ltd. | 04/04/2002SE |
| K020024 | Caris Minitome Biopsy InstrumentKNW · Traditional | Artemis Medical, Inc. | 04/03/2002SE |
| K013692 | Trapsystem SetKNW · Traditional | H.S. Hospital Service S.R.L. | 02/05/2002SE |
| K012088 | Nastech Mammary Aspiration Speciman Cytology Test MasctKNW · Traditional | Nastech Pharmaceutical Company, Inc. | 12/18/2001SE |
| K012023 | Anchor Guide Lesion Localization Device; Ancor Guide Holder; RF Generator CableKNW · Traditional | Senorx, Inc. | 09/12/2001SE |
| K012224 | Single Action Biopsy Needle, Model RCBS: XX Gauge, XX Length, XX ThrowKNW · Traditional | Ranfac, Corp. | 08/22/2001SE |
| K011575 | 22MM Siteselect Breast Biopsy Device Model SSD022KNW · Traditional | Imagyn Surgical | 08/17/2001SE |
| K010735 | SpeedybellKNW · Traditional | Biopsybell S.A.S. | 08/17/2001SE |
| K010400 | Vacuum Assisted Core Biopsy DeviceKNW · Traditional | Promex, Inc. | 07/24/2001SE |
| K011206 | Parallax Bone and Vertebral Body Biopsy and Infusion NeedlesKNW · Abbreviated | Parallax Medical, Inc. | 07/18/2001SE |
| K011104 | OsteobellKNW · Traditional | Biopsybell S.A.S. | 05/31/2001SE |
| K003528 | Sanarus Core Tissue Biopsy SystemKNW · Traditional | Endocare, Inc. | 05/03/2001SE |
| K010037 | Daum Double-Shoot Bisopsy GunKNW · Traditional | Daum GmbH | 03/22/2001SE |
| K003297 | Mammotome Hand Held Probe, Model MHH8KNW · Traditional | Ethicon Endo-Surgery, Inc. | 01/18/2001SE |
| K003439 | Vivant Breast Lesion Localization DeviceKNW · Traditional | Vivant Medical, Inc. | 12/15/2000SE |
| K003370 | Jamshidi Marrow Acquisition CradleKNW · Special | Allegiance Healthcare Corp. | 11/22/2000SE |
| K002546 | Civ-Flex Holster Cover, Model Sterile, Latex-FreeKNW · Traditional | CIVCO Medical Instruments Co., Inc. | 10/31/2000SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2709-2026 Class I | Bone Marrow Tray, REF: CB0033TL; CB0355TLAKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | Argon Medical Devices, Inc | 06/01/2026Open, Classified |
| Z-2707-2026 Class I | T-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATLKits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | Argon Medical Devices, Inc | 06/01/2026Open, Classified |
| Z-2706-2026 Class I | General Biospy Tray, REF: GUTS1000Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to… | Argon Medical Devices, Inc | 06/01/2026Open, Classified |
| Z-1314-2026 Class II | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.Presence of particulates in affected devices that can be deposited into breast tissue during use. | Hologic, Inc | 12/15/2025Open, Classified |
| Z-1170-2025 Class II | Brand Name: Sertera Biopsy Device Product Name: Sertera Biopsy Device Model/Catalog…Devices presented a condition in which the inner needle separated from the hub and produced a longer throw… | Hologic, Inc | 01/15/2025Open, Classified |
| Z-0467-2025 Class II | Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF:…Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on… | Bard Peripheral Vascular Inc | 09/30/2024Open, Classified |
| Z-3192-2024 Class II | BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02…Holes have been identified in biopsy instrument packaging trays compromising the sterile barrier, which may… | Argon Medical Devices, Inc | 07/02/2024Open, Classified |
| Z-0643-2024 Class II | Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G…The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the… | Bard Peripheral Vascular Inc | 11/08/2023Open, Classified |
| Z-0027-2024 Class II | Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument… | Bard Peripheral Vascular Inc | 08/10/2023Open, Classified |
| Z-2035-2023 Class II | Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from…The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery | Hologic, Inc | 05/02/2023Open, Classified |
| Z-1564-2023 Class II | Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF:…Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length… | Bard Peripheral Vascular Inc | 04/11/2023Open, Classified |
| Z-1260-2023 Class II | Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x…The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle… | Bard Peripheral Vascular Inc | 02/28/2023Open, Classified |
| Z-0771-2023 Class II | Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1)The stylet is longer than specified on the label | Remington Medical, Inc. | 12/02/2022Terminated |
| Z-0138-2023 Class II | CorVocet Biopsy System, Catalog Code: CORA1410/B, CORA1410S/B, CORA1415/B, CORA1615S/B…Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly… | Merit Medical Systems, Inc. | 08/03/2022Open, Classified |
| Z-0137-2023 Class II | CorVocet Biopsy System/Catalog Code: CORA1610/B, CORA1610S/B, CORA1615/B, CORA1810/A…Biopsy Systems have components that are misaligned due to an issue with the manufacturing assembly… | Merit Medical Systems, Inc. | 08/03/2022Open, Classified |
| Z-0354-2022 Class II | SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR…Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments. | Argon Medical Devices, Inc | 10/04/2021Open, Classified |
| Z-0154-2022 Class II | Catalog # BEK3411, Ecomomy Jamshidi Bone Marrow Biopsy Tray, 11 G X 4"Biopsy/Aspiration…Due to misbranded products shipped to customers. | Bard Peripheral Vascular Inc | 08/24/2021Terminated |
| Z-0153-2022 Class II | Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11…Due to misbranded products shipped to customers. | Bard Peripheral Vascular Inc | 08/24/2021Terminated |
| Z-2492-2021 Class II | Soft Tissue Biopsy NeedlesSterility assurance may be compromised. | M.D.L. S.r.l. | 08/05/2021Terminated |
| Z-2249-2021 Class II | TIN3018 Illinois Bone Marrow Aspiration/Intraosseous Infusion Needle 18G x 79mm TIN3015…Due to complaints received regarding incomplete/open packaging seals potentially causing product to… | Bard Peripheral Vascular Inc | 06/23/2021Open, Classified |
| Z-2248-2021 Class II | EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G…Due to complaints received regarding incomplete/open packaging seals potentially causing product to… | Bard Peripheral Vascular Inc | 06/23/2021Open, Classified |
| Z-2247-2021 Class II | TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition…Due to complaints received regarding incomplete/open packaging seals potentially causing product to… | Bard Peripheral Vascular Inc | 06/23/2021Open, Classified |
| Z-1634-2021 Class II | BPB medica OSTEOBELL EXPLANT NEEDLE FOR BONE MARROW EXPLANT, 110 mm, 11 G, REF OBE1111Products labeled as sterile were distributed, but may not have been sterilized. | Biopsybell S.R.L. | 03/22/2021Terminated |
| Z-1374-2021 Class II | Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy…Difficulty inserting the biopsy ejector rod into the bone lesion biopsy cannula, preventing the biopsy… | Arrow International Inc | 03/08/2021Open, Classified |
| Z-1289-2021 Class II | BARD MARQUEE Disposable Core Biopsy Instruments XX.Xcm, XX.Xcm, XXg x XXcm REF XXXXXXX…Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for… | Bard Peripheral Vascular Inc | 01/14/2021Terminated |
| Z-1689-2020 Class II | Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer Lock Adapter 11GX4 ASP, Sterile…Sterility compromised due to packaging pouches that may not be sealed properly | Bard Peripheral Vascular Inc | 03/17/2020Terminated |
| Z-1434-2020 Class II | Bard Biopsy EnCor Probe, MRI, 10G Blunt Tip, REF number ECPMR0110GBT, packaged…Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was… | Bard Peripheral Vascular Inc | 01/03/2020Terminated |
| Z-1433-2020 Class II | Bard Biopsy EnCor Probe, MRI, 10G Trocar Tip, REF number ECPMR0110G, packaged…Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was… | Bard Peripheral Vascular Inc | 01/03/2020Terminated |
| Z-1432-2020 Class II | Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number ECPMR017G, packaged individually…Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was… | Bard Peripheral Vascular Inc | 01/03/2020Terminated |
| Z-1431-2020 Class II | Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged…Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was… | Bard Peripheral Vascular Inc | 01/03/2020Terminated |
| Z-0988-2020 Class II | Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the… | Zimmer Biomet, Inc. | 12/23/2019Terminated |
| Z-2427-2020 Class II | BioPince Full Core Biopsy Instrument 16ga x 15cm.,Use with Optional CO-Axial Needle…Incorrect product labeling. | Argon Medical Devices, Inc | 12/02/2019Terminated |
| Z-0724-2020 Class II | BARD MAX-CORE Disposable Core Biopsy Instrument - Product Usage: The core needle biopsy…During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy… | Bard Peripheral Vascular Inc | 10/25/2019Terminated |
| Z-2411-2019 Class II | 8 G x 10 CM Jamshidi Crown Bone Marrow biopsy/Aspiration Needle with MAC Catalog Number:…Product Pouches may not be sealed properly and compromise the sterility of the device | Becton Dickinson & Company | 08/01/2019Terminated |
| Z-2214-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | Bard Peripheral Vascular Inc | 05/02/2019Terminated |
| Z-2213-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | Bard Peripheral Vascular Inc | 05/02/2019Terminated |
| Z-2212-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | Bard Peripheral Vascular Inc | 05/02/2019Terminated |
| Z-2211-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | Bard Peripheral Vascular Inc | 05/02/2019Terminated |
| Z-2210-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | Bard Peripheral Vascular Inc | 05/02/2019Terminated |
| Z-2209-2019 Class II | EnCor Breast Biopsy Probes, packaged individually in sterile pouches, 5 pouches/carton…There has been an increase in complaints related to leaks, suction issues, and failure to obtain samples… | Bard Peripheral Vascular Inc | 05/02/2019Terminated |
| Z-1492-2019 Class II | Fenestrated Tap Adapter (REF# 5001-90011) Product Usage: The K2M Fenestrated Tap System…The products are mislabeled. | K2M, Inc | 04/18/2019Terminated |
| Z-1491-2019 Class II | Fenestrated Taps 4.5mm, 5.5mm, 6.5mm (Ref#5001-90013, 5001-90014, 5001-90015) Product…The products are mislabeled. | K2M, Inc | 04/18/2019Terminated |
| Z-1047-2019 Class II | Avitus Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and…Breach in the sterile barrier pouch may compromise sterility of the device. | Avitus Orthopaedics, Inc. | 02/18/2019Terminated |
| Z-1046-2019 Class II | Avitus Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and…Breach in the sterile barrier pouch may compromise sterility of the device. | Avitus Orthopaedics, Inc. | 02/18/2019Terminated |
| Z-0044-2018 Class II | BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm…During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy… | Bard Peripheral Vascular Inc | 09/22/2017Terminated |
| Z-1512-2017 Class II | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast…The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the… | Devicor Medical Products Inc | 02/28/2017Terminated |
| Z-1196-2017 Class II | HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow…The recalling firm received a complaint from one of their customers of a potential defect in the forming of… | Argon Medical Devices, Inc | 01/18/2017Terminated |
| Z-1195-2017 Class II | T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4…The recalling firm received a complaint from one of their customers of a potential defect in the forming of… | Argon Medical Devices, Inc | 01/18/2017Terminated |
| Z-1194-2017 Class II | BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose…The recalling firm received a complaint from one of their customers of a potential defect in the forming of… | Argon Medical Devices, Inc | 01/18/2017Terminated |
| Z-1136-2017 Class II | Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable…Product sterility compromised due to breach of sterile barrier | Medtronic Advanced Energy, LLC | 12/28/2016Terminated |