Biopsy Device Accessory
FDA 510(k) K945573 · Biopsys Medical, Inc.
510(k) numberK945573
Submission
- Device name
- Biopsy Device Accessory
- Applicant
- Biopsys Medical, Inc.
San Juan Capistrano, CA, US - Received
- November 14, 1994
- Decision date
- December 9, 1994
- 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 |
|---|---|---|
| K970817 | Micromark ClipGDW · Traditional | 09/11/1997SE |
| K970565 | Mammotome Biopsy Probe and Housing (Mammotome)KNW · Traditional | 03/28/1997SE |
| K963015 | Surgical Staple Marker Device (Modify)GDW · Traditional | 10/07/1996SE |
| K960019 | Retractor Arm ClampFWZ · Traditional | 02/09/1996SE |
| K953962 | ForcepsGEN · Traditional | 09/08/1995SE |
| K953880 | Biopsy NeedleKNW · Traditional | 09/08/1995SE |
| K951326 | Biopsy Device AccessoryBTA · Traditional | 05/15/1995SE |
| K951229 | Modified Biopsy NeedleKNW · Traditional | 04/06/1995SE |
| K950006 | Surgical Staple MarkerGDW · Traditional | 03/15/1995SE |
| K943863 | Needle GuideIYN · Traditional | 12/29/1994SE |
Questions and answers
When was Biopsy Device Accessory cleared by the FDA?
Biopsy Device Accessory (K945573) received a 510(k) decision of Substantially Equivalent on December 9, 1994, 25 days after the submission was received.
What is the product code of K945573?
The FDA product code is KNW – Instrument, Biopsy, a Class II (moderate risk) device regulated under 21 CFR 876.1075.