# K100896: Gyrus Acmi Halo PKS Cutting Forceps

- Pathway: 510(k) (Special)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jun 17, 2010 after 78 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K936109 (1994). 72 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023492: Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting Forceps, Gyrus Medical, Inc. (2002) Summary page 1.
- K050550: Gyrus General Purpose Electrosurgical Generator, Gyrus Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- 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-1641-2026: 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

## Indications for use
The Gyrus AGMI® HALO PKS Cutting Forceps are indicated for electrosurgical coagulation, mechanical cutting and grasping of tissue during the performance of laparoscopic and open general surgical procedures when used in conjunction with the Cyrus ACMI General Surgery Generator (G400).

Source page: https://510kreport.com/device/K100896
Methodology: https://510kreport.com/methodology