# K023492: Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting Forceps

- Pathway: 510(k) (Special)
- Applicant: Gyrus Medical, Inc.
- Decided: Nov 13, 2002 after 26 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904993 (1991). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904993: Laparoscopic Electrosurgical Device, Everest Medical Corp. (1991) Summary page 1.

## Most influential descendants
- K100896: Gyrus Acmi Halo PKS Cutting Forceps (2010), 3 descendants of its own
- K142759: PK Cutting Forceps for ESG-400 Workstation (2015), 2 descendants of its own
- K203277: Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps (2021), 1 descendant of its own
- 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-1643-2026: 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
- Feb 25, 2026 · Class II · Z-1639-2026: 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
- Feb 25, 2026 · Class II · Z-1638-2026: 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
- Feb 25, 2026 · Class II · Z-1642-2026: 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
- Feb 25, 2026 · Class II · Z-1644-2026: 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 1, 2024 · Class II · Z-2542-2024: Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
- Jul 1, 2024 · Class II · Z-2540-2024: Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
- Jul 1, 2024 · Class II · Z-2541-2024: Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach

## Indications for use
Electrosurgical coagulation, mechanical cutting, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.

Source page: https://510kreport.com/device/K023492
Methodology: https://510kreport.com/methodology