# Genzyme Surgical Product (Genzyme Biosurgery)

- Location (FDA's records): Fall River, MA
- FDA decisions: 9 (1998–2000): 9 510(k) clearances
- Product codes: GAM (2), GAT (2), MOP (1), GCJ (1), GAR (1), MDM (1), CAC (1)
- Predicates its devices cite: 19 (1 its own); citations of its devices by later devices: 17 (1 its own)
- Recalls linked to its devices: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Carbomedics, Inc.: 2 (https://510kreport.com/company/carbomedics)
- Pfizer Hospital Products Group, Inc.: 2 (https://510kreport.com/company/pfizer-hospital-products-group)
- Davis & Geck, Inc.: 2 (https://510kreport.com/company/davis-geck)
- Lukens Medical Corp.: 2 (https://510kreport.com/company/lukens-medical)
- Karl Storz Imaging, Inc.: 2 (https://510kreport.com/company/karl-storz-imaging)
- ETHICON, Inc.: 2 (https://510kreport.com/company/ethicon)
- Snowden-Pencer: 1 (https://510kreport.com/company/snowden-pencer)
- American Cyanamid Co.: 1 (https://510kreport.com/company/american-cyanamid)

## Firms that cite its devices most
- Arthrex, Inc.: 3 (https://510kreport.com/company/arthrex)
- Teleflex Medical: 3 (https://510kreport.com/company/teleflex-medical)
- Coloplast A/S: 2 (https://510kreport.com/company/coloplast-a-s)
- Axya Medical, Inc.: 2 (https://510kreport.com/company/axya-medical)
- Implicitcare, LLC: 1 (https://510kreport.com/company/implicitcare)
- Teleflexmedical, Inc.: 1 (https://510kreport.com/company/teleflexmedical)
- Genzyme Biosurgery: 1 (https://510kreport.com/company/genzyme-biosurgery)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)

## Its most-cited devices
- K001434: 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture (2000), cited by 7
- K992088: Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture (1999), cited by 4
- K991191: Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture (1999), cited by 3
- K001440: Nextstitch Cardiovascular Valve Suture (2000), cited by 3

## Recent decisions
- K001440: Nextstitch Cardiovascular Valve Suture (Nov 13, 2000)
- K001434: 'Cottony' II Dacron, Silky II Polydek & Tevdek II Polyester Nonabsorbable Surgical Suture (Jun 12, 2000)
- K992088: Bondek Plus Polyglycolic Acid Synthetic Absorbable Surgical Suture (Sep 3, 1999)
- K991416: Endoscopic Camera (Jul 20, 1999)
- K991191: Bondek Polyglycolic Acid Synthetic Absorbable Surgical Suture (Jun 22, 1999)
- K990062: Saphlift (Mar 30, 1999)
- K982712: Rapid Transfer Blood Bag Model a-1650, Rapid Transfer Blood Bag Model S-250 (Dec 18, 1998)
- K980016: Millennium Valve Introducer/Rotator Handle (Aug 7, 1998)

Source page: https://510kreport.com/company/genzyme-surgical-product-genzyme-biosurgery