# K964736: Bergen 610 Bipolar Coagulator

- Pathway: 510(k) (Traditional)
- Applicant: Bergen Mfg.
- Decided: Feb 27, 1997 after 94 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
979 later devices descend from it; 2 cite it directly.
0 of 980 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K972299: Bergen Model 500 Electrosurgery Generator (1997), 978 descendants of its own
- K974521: Vnus Closure System (1998), 977 descendants of its own
- K982816: Vnus Closure System (1999), 973 descendants of its own
- K012398: Diomed 15 Diode Laser (2002), 714 descendants of its own
- K022266: Aurora SR (2002), 705 descendants of its own

Source page: https://510kreport.com/device/K964736
Methodology: https://510kreport.com/methodology