# K161038: PK Morcellator

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Oct 7, 2016 after 177 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: 10 generations back to K936109 (1994). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080093: PKS Plasma Morcellator, Models 962000PK, 3620PK, Gyrus Acmi, Inc. (2008) Summary page 4.

## Indications for use
The PK Morcellator is intended for cutting, and extracting tissue in laparoscopic gynecologic procedures. It is recommended to use the PK Morcellator in conjunction with the PneumoLiner containment device (WA90500US) for removal of uterine tissue.

Source page: https://510kreport.com/device/K161038
Methodology: https://510kreport.com/methodology