# K161825: PK AIM

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Sep 26, 2016 after 87 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). 103 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152219: PK AIM, Gyrus Acmi, Inc. (2015) Summary page 5.
- K081766: PKS Omni Instrument, Gyrus-Acmi L.P. (2008) Summary page 5.

## Most influential descendants
- K163373: PK AIM (2016), 1 descendant of its own
- K170908: PK AIM (2017), 0 descendants of its own

## Indications for use
The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.

Source page: https://510kreport.com/device/K161825
Methodology: https://510kreport.com/methodology