# K103032: Esg-400 Model WB95051N, Footswitch Double Pedal Model WB50402W, Footswitch Single Pedal Model WB50403W, P-Cord Model Maj

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Jan 14, 2011 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
Longest line of descent: 4 generations back to K911904 (1991). 12 ancestors in all.
12 later devices descend from it; 1 cites it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023886: Erbe Vio Esu with Accessories, Model Vio 300 D, Erbe USA, Inc. (2002) Summary page 2.
- K060484: Erbe Vio Esu, Model Vio 300 D, Erbe USA, Inc. (2006) Summary page 2.
- K030194: Xues-41 Endoscopic Electrosurgical Unit, The Olympus Optical Co. (2003) Summary page 2.

## Most influential descendants
- K141225: Esg-400, Footswitch Double Pedal, Footswitch Single Pedal, P-Cord (2014), 11 descendants of its own
- K211838: Ultrasonic Bipolar Generator USG-410 with accessories (2021), 3 descendants of its own
- K203682: Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action (2021), 2 descendants of its own
- K212643: POWERSEAL Curved Jaw Sealer and Divider, Double Action (2021), 1 descendant of its own
- K203277: Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps (2021), 1 descendant of its own

## Indications for use
The Olympus ESG-400 electrosurgical unit is intended for cutting and coagulation of tissue in open, laparoscopic and endloscopic surgery in conjunction with electrosurgical accessories and ancillary equipment.

Source page: https://510kreport.com/device/K103032
Methodology: https://510kreport.com/methodology