Interv Brand Snarelok Bone Marrow Biopsy Needle
FDA 510(k) K043523 · Medical Device Technologies, Inc.
510(k) numberK043523
Submission
- Device name
- Interv Brand Snarelok Bone Marrow Biopsy Needle
- Applicant
- Medical Device Technologies, Inc.
Wheeling, IL, US - Received
- December 20, 2004
- Decision date
- February 11, 2005
- 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 |
|---|---|---|
| K101832 | Biopince Ultra Full Core Biopsy InstrumentKNW · Traditional | 08/27/2010SE |
| K053518 | Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Special | 01/26/2006SE |
| K051421 | Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Traditional | 08/30/2005SE |
| K050873 | Canalizer Hydrophilic Guide WireDQX · Traditional | 05/26/2005SE |
| K042464 | V-Core Full Core Breast Biopsy InstrumentKNW · Traditional | 09/30/2004SE |
| K040427 | Fibrex Catheter Patency DeviceFOZ · Traditional | 05/03/2004SE |
| K031442 | PBN GuidewiresDQX · Traditional | 08/13/2003SE |
| K021606 | En-Snare Endovascular Snare and CatheterMMX · Traditional | 05/31/2002SE |
| K011790 | Microcruiser Plus Introducer SetDYB · Traditional | 09/05/2001SE |
| K000620 | PBN Fallopian Tube Catheter SystemMDG · Traditional | 10/30/2000SE |
Questions and answers
When was Interv Brand Snarelok Bone Marrow Biopsy Needle cleared by the FDA?
Interv Brand Snarelok Bone Marrow Biopsy Needle (K043523) received a 510(k) decision of Substantially Equivalent on February 11, 2005, 53 days after the submission was received.
What is the product code of K043523?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.