# K080093: PKS Plasma Morcellator, Models 962000PK, 3620PK

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: May 2, 2008 after 109 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). 69 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 71 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 1.
- K993801: Gynecare Laparoscopic Morcellator, ETHICON, Inc. (2000) Summary page 1.

## Most influential descendants
- K161038: PK Morcellator (2016), 0 descendants of its own

## Indications for use
The Gyrus ACMI PKS Plasma Morcellator is intended for cutting, coring, and extracting tissue in various operative laparoscopy procedures, including laparoscopic general surgical procedures, laparoscopic urological procedures, and laparoscopic gynecologic procedures.

Source page: https://510kreport.com/device/K080093
Methodology: https://510kreport.com/methodology