# Biopsys Medical, Inc.

- Location (FDA's records): San Juan Capistrano, CA
- FDA decisions: 15 (1994–1997): 15 510(k) clearances
- Product codes: KNW (6), GDW (3), FCK (1), FCG (1), FWZ (1), GEN (1), BTA (1), IYN (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- United States Surgical, A Division of Tyco Healthc: 2 (https://510kreport.com/company/united-states-surgical-a-division-of-tyco-healthc)
- Mri Devices Corp.: 1 (https://510kreport.com/company/mri-devices)
- Bip USA, Inc.: 1 (https://510kreport.com/company/bip-usa)
- Inrad: 1 (https://510kreport.com/company/inrad)
- Biopsy Sciences, LLC: 1 (https://510kreport.com/company/biopsy-sciences)
- Artemis Medical, Inc.: 1 (https://510kreport.com/company/artemis-medical)

## Its most-cited devices
- K970817: Micromark Clip (1997), cited by 4
- K970565: Mammotome Biopsy Probe and Housing (Mammotome) (1997), cited by 3

## Recent decisions
- K970817: Micromark Clip (Sep 11, 1997)
- K970565: Mammotome Biopsy Probe and Housing (Mammotome) (Mar 28, 1997)
- K963015: Surgical Staple Marker Device (Modify) (Oct 7, 1996)
- K960019: Retractor Arm Clamp (Feb 9, 1996)
- K953962: Forceps (Sep 8, 1995)
- K953880: Biopsy Needle (Sep 8, 1995)
- K951326: Biopsy Device Accessory (May 15, 1995)
- K951229: Modified Biopsy Needle (Apr 6, 1995)

Source page: https://510kreport.com/company/biopsys-medical