# K163373: PK AIM

- Pathway: 510(k) (Special)
- Applicant: Gyrus Acmi, Inc.
- Decided: Dec 12, 2016 after 11 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: 12 generations back to K936109 (1994). 104 ancestors in all.
1 later device descends 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)
- K161825: PK AIM, Gyrus Acmi, Inc. (2016) Summary page 4.

## Most influential descendants
- 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/K163373
Methodology: https://510kreport.com/methodology