# K972299: Bergen Model 500 Electrosurgery Generator

- Pathway: 510(k) (Traditional)
- Applicant: Bergen Mfg.
- Decided: Aug 27, 1997 after 69 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
Longest line of descent: 1 generation back to K945861 (1995). 2 ancestors in all.
978 later devices descend from it; 1 cites it directly.
0 of 981 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945861: Bergen 710 Esu, Bergen Mfg. (1995) Summary page 1.
- K964736: Bergen 610 Bipolar Coagulator, Bergen Mfg. (1997) Summary page 1.

## Most influential descendants
- 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
- K020339: Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser System (2002), 695 descendants of its own

## Indications for use
The Bergen Model 500 Generator is a general purpose solid state generator to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

Source page: https://510kreport.com/device/K972299
Methodology: https://510kreport.com/methodology