# K955166: Penevac SI.

- Pathway: 510(k) (Traditional)
- Applicant: I.C Medical, Inc.
- Decided: Apr 11, 1996 after 150 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Telescoping PenEvac (I.C. Medical): named in the summary without a submission number
- (no number) Disposable Laparoscopic Handswitch (Valleylab): named in the summary without a submission number

## Most influential descendants
- K960492: SI Controller Model SI 500 (1996), 0 descendants of its own

## Indications for use
The PenEvac SI is a multifunction handpiece that is meant to provide the following optional functions: monopolar electrode handpiece in an electrosurgery generator system, suction, irrigation, and to facilitate the removal of smoke generated during the procedure. The intended use is the same as the predicate devices.

Source page: https://510kreport.com/device/K955166
Methodology: https://510kreport.com/methodology