# K170908: PK AIM

- Pathway: 510(k) (Traditional)
- Applicant: Gyrus Acmi, Inc.
- Decided: May 19, 2017 after 52 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: 14 generations back to K936109 (1994). 167 ancestors in all.
No later device cites it as a predicate yet.
0 of 168 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163373: PK AIM, Gyrus Acmi, Inc. (2016) Summary page 4.
- K151743: THUNDERBEAT Open Fine Jaw, Olympus Medical Systems Corp. (2016) Summary page 4.

## Indications for use
The PK AIM is indicated for open, general surgery (including plastic and re-constructive) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed. The device has been designed to seal and cut vessels (up to and including 3 mm in diameter), tissue bundles, and lymphatics when used with the Olympus ESG-400 Generator. This device is not intended to be used for tubal ligation or female sterilization.

Source page: https://510kreport.com/device/K170908
Methodology: https://510kreport.com/methodology