# K160639: Electrosurgical Generator ESG-200

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: May 4, 2016 after 58 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: 9 generations back to K943450 (1995). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141225: Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord, Olympus Winter & Ibe GmbH (2014) Summary page 4.
- K040638: Vnus Radiofrequency Generator, Model RFG2, Vnus Medical Technologies, Inc. (2004) Summary page 4.
- K032838: Celon Ent System, Celon AG Medical Instruments (2003) Summary page 4.

## Indications for use
Electrosurgical generator intended for tissue cutting and coagulation in conjunction with electrosurgical accessories and ancillary equipment.

Source page: https://510kreport.com/device/K160639
Methodology: https://510kreport.com/methodology