# K182587: Device Electrosurgical Generator ESG-150

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Nov 29, 2018 after 70 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: 6 generations back to K911904 (1991). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 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.

## Indications for use
The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulating tissue in endoscopic surgery.

Source page: https://510kreport.com/device/K182587
Methodology: https://510kreport.com/methodology