# K142350: PK J-Hook

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jan 8, 2015 after 139 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). 68 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050460: Gyrus Plasmacision and Plasmablend Electrodes, Gyrus Medical, Inc. (2005) Summary page 4.

## Most influential descendants
- K213831: Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle (2022), 0 descendants of its own

## Recalls of this device
- Oct 23, 2020 · Class II · Z-0472-2021: Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to 

## Indications for use
The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

Source page: https://510kreport.com/device/K142350
Methodology: https://510kreport.com/methodology