# Genzyme Biosurgery

- Location (FDA's records): Fall River, MA
- FDA decisions: 5 (2002–2004): 4 510(k) clearances and 1 original PMA approval
- Product codes: FSW (1), GAT (1), CAC (1), NEW (1), LMH (1)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 6 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Snowden-Pencer: 1 (https://510kreport.com/company/snowden-pencer)
- Ethicon Endo-Surgery, Inc.: 1 (https://510kreport.com/company/ethicon-endo-surgery)
- Genzyme Surgical Product (Genzyme Biosurgery): 1 (https://510kreport.com/company/genzyme-surgical-product-genzyme-biosurgery)
- Deknatel, Inc.: 1 (https://510kreport.com/company/deknatel)
- Cp Medical: 1 (https://510kreport.com/company/cp-medical)

## Firms that cite its devices most
- Sentreheart, Inc.: 2 (https://510kreport.com/company/sentreheart)
- Tlelflex Medical, Inc.: 1 (https://510kreport.com/company/tlelflex-medical)
- Teleflex Medical: 1 (https://510kreport.com/company/teleflex-medical)
- Coloplast A/S: 1 (https://510kreport.com/company/coloplast-a-s)
- Epitek, Inc.: 1 (https://510kreport.com/company/epitek)

## Its most-cited devices
- K022410: Saph-Loop Ligating Loop (2002), cited by 3
- K030212: Monodek Synthetic Absorbable Surgical Suture (2003), cited by 2
- K031554: S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System (2003), cited by 1

## Recent decisions
- P030032: Hylaform (Hylan B Gel) (Apr 22, 2004)
- K031554: S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System (Jul 25, 2003)
- K030212: Monodek Synthetic Absorbable Surgical Suture (Mar 27, 2003)
- K022989: Radlite Tissue Retractor System (Nov 25, 2002)
- K022410: Saph-Loop Ligating Loop (Aug 20, 2002)

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