# K152219: PK AIM

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: Dec 17, 2015 after 132 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: 7 generations back to K923332 (1992). 23 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K813071: E2508 Disposable Handswitching Pencil, Valleylab, Inc. (1981) Summary page 5.
- K093108: Stryker Bipolar Forceps, Stryker Leibinger GmbH & Co KG (2010) Summary page 5.
- K063195: Ligasure Advance Laparoscopic Sealer/Divider with Dissecting Electrode, Models LF5034 and LF5044, Valleylab (2006) Summary page 5.

## Most influential descendants
- K161825: PK AIM (2016), 2 descendants of its own
- K163373: PK AIM (2016), 1 descendant of its own
- K170908: PK AIM (2017), 0 descendants of its own

## Indications for use
The PK AIM device is intended for monopolar cutting as well as grasping, manipulating and bipolar coagulation of selected soft tissues during electrosurgery. This device is not intended to be used for tubal ligation or female sterilization.

Source page: https://510kreport.com/device/K152219
Methodology: https://510kreport.com/methodology