Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018
FDA 510(k) K093256 · Inrad
510(k) numberK093256
Submission
- Device name
- Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018
- Applicant
- Inrad
Kentwood, MI, US - Received
- October 19, 2009
- Decision date
- November 17, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KNW – Instrument, Biopsy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1075
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNW
| 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 |
More from Forcyte Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K243886 | ExpressCore Biopsy DeviceKNW · Traditional | 04/29/2025SE |
| K240429 | Trilogy Tissue MarkerNEU · Traditional | 11/07/2024SE |
| K183503 | EasyMark Tissue MarkerNEU · Traditional | 10/17/2019SE |
| K112945 | Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, With/Hilitier 18GAX10CM…KNW · Special | 11/03/2011SE |
| K093399 | Precisecore 10 MM Biopsy Device- 14GA X 5 CM Model 670514, 671014, 670518 671018, 670520KNW · Traditional | 11/19/2009SE |
| K090611 | Revolution Full Core BiopsyKNW · Traditional | 06/04/2009SE |
| K063238 | Ultraclip II Wing and Ultraclip II CoilNEU · Traditional | 01/30/2007SE |
| K042341 | Ultraclip II USNEU · Special | 09/20/2004SE |
| K041201 | Ultraclip II MRGDW · Special | 06/03/2004SE |
| K000612 | Accucore Single Action Core Biopsy DeviceKNW · Traditional | 04/24/2000SE |
Questions and answers
When was Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018 cleared by the FDA?
Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018 (K093256) received a 510(k) decision of Substantially Equivalent on November 17, 2009, 29 days after the submission was received.
What is the product code of K093256?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.