# Bergen Mfg.

- Location (FDA's records): New Port Richey, FL
- FDA decisions: 4 (1986–1997): 4 510(k) clearances
- Product codes: GEI (3), HAM (1)
- Predicates its devices cite: 2 (2 its own); citations of its devices by later devices: 4 (2 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
- Vnus Medical Technologies, Inc.: 2 (https://510kreport.com/company/vnus-medical-technologies)

## Its most-cited devices
- K964736: Bergen 610 Bipolar Coagulator (1997), cited by 2
- K972299: Bergen Model 500 Electrosurgery Generator (1997), cited by 1
- K945861: Bergen 710 Esu (1995), cited by 1

## Recent decisions
- K972299: Bergen Model 500 Electrosurgery Generator (Aug 27, 1997)
- K964736: Bergen 610 Bipolar Coagulator (Feb 27, 1997)
- K945861: Bergen 710 Esu (Mar 1, 1995)
- K863701: Model 709 Bipolar Micro Coagulator (Oct 14, 1986)

Source page: https://510kreport.com/company/bergen-mfg