# K955020: Penevac Abc Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: I.C Medical, Inc.
- Decided: Apr 9, 1996 after 159 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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 2.
- (no number) Valleylab Force GSU Handset: named in the summary without a submission number

## Most influential descendants
- K113500: Canady Vieira Hybrid Plasma Scalpel (2011), 0 descendants of its own

## Indications for use
The Telescoping PenEvac ABC is intended to be used only during open surgical procedures as the active handpiece in a combination argon beam coagulator/electrosurgery generator system that uses monopolar electrodes and to facilitate the removal of smoke that is generated.

Source page: https://510kreport.com/device/K955020
Methodology: https://510kreport.com/methodology