# K213831: Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle

- Pathway: 510(k) (Special)
- Applicant: Gyrus Acmi, Inc.
- Decided: Jan 4, 2022 after 27 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: 11 generations back to K936109 (1994). 73 ancestors in all.
No later device cites it as a predicate yet.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142154: PK Needle, Gyrus Acmi, Inc. (2014) Summary page 4.
- K142289: PK Spatula, Gyrus Acmi, Inc. (2014) Summary page 4.
- K142350: PK J-Hook, Gyrus Acmi, Inc. (2015) Summary page 4.

## Indications for use
1. The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures. 2. The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures. 3. The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.

Source page: https://510kreport.com/device/K213831
Methodology: https://510kreport.com/methodology