# K142289: PK Spatula

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Dec 31, 2014 after 135 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 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)
- K041633: Gyrus Plasmacision Laparoscopic Spatula, Gyrus Medical, Inc. (2004) Summary page 4.

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

## Indications for use
The PK Spatula 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/K142289
Methodology: https://510kreport.com/methodology