# K231777: Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W)

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Aug 18, 2023 after 63 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K936109 (1994). 169 ancestors in all.
No later device cites it as a predicate yet.
0 of 170 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203277: Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps, Olympus Winter & Ibe GmbH (2021) Summary page 5.
- K211838: Ultrasonic Bipolar Generator USG-410 with accessories, Olympus Medical Systems Corporation (2021) Summary page 5.

## Recalls of this device
- Jul 25, 2025 · Class II · Z-2338-2025: Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
- Sep 4, 2024 · Class II · Z-0264-2025: There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).

## Indications for use
The electrosurgical generator, in conjunction with compatible devices and electrosurgical accessories, is intended for cutting and coagulation of soft tissue and for ligation of vessels. The electrosurgical generator utilizes monopolar and bipolar high frequency current and supports ultrasonic instruments. The electrosurgical generator is intended to be used in the following medical fields: • Open surgery • Laparoscopic surgery, including single-site surgery • Endoscopic surgery Only for use by a qualified physician in an adequate medical environment.

Source page: https://510kreport.com/device/K231777
Methodology: https://510kreport.com/methodology