# K142154: PK Needle

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Dec 19, 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: 2 generations back to K904993 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031079: Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode, Gyrus Medical, Inc. (2003) Summary page 4.
- (no number) Gyrus Bipolar Needle: named in the summary without a submission number

## 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 Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

Source page: https://510kreport.com/device/K142154
Methodology: https://510kreport.com/methodology