# K203277: Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Winter & Ibe GmbH
- Decided: Apr 28, 2021 after 173 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K936109 (1994). 88 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 90 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 6.
- K142759: PK Cutting Forceps for ESG-400 Workstation, Gyrus Acmi, Inc. (2015) Summary page 6.

## Most influential descendants
- K231777: Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) (2023), 0 descendants of its own

## Recalls of this device
- Feb 25, 2026 · Class II · Z-1640-2026: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking d
- Jul 25, 2025 · Class II · Z-2339-2025: 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'.
- Jun 21, 2024 · Class II · Z-2415-2024: Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery
- Dec 15, 2023 · Class II · Z-1167-2024: The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.

## Indications for use
The electrosurgical generator, in conjunction with electrosurgical accessories and ancillary equipment, is intended for cutting and coagulation of tissue in the following medical fields: * Open surgery * Laparoscopic surgery * Endoscopic surgery Only for use by a qualified physician in an adequate medical environment. The PK Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting, and grasping of tissue during the performance of laparoscopic and open general surgical procedures.

Source page: https://510kreport.com/device/K203277
Methodology: https://510kreport.com/methodology