# K160160: Non-Telescopic PenEvac

- Pathway: 510(k) (Special)
- Applicant: I.C Medical, Inc.
- Decided: Apr 5, 2016 after 69 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: 1 generation back to K954088 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954088: Telescoping Penevac, I.C Medical, Inc. (1995) Summary page 4.

## Indications for use
The PenEvac® is intended to be used as the active Monopolar electrode in an electrosurgery generator system and to facilitate the removal of smoke that is generated during procedures.

Source page: https://510kreport.com/device/K160160
Methodology: https://510kreport.com/methodology