# K961616: Telescoping Penevac (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: I.C Medical, Inc.
- Decided: May 28, 1996 after 36 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 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) Valleylab Disposable Handswitching Pencil: named in the summary without a submission number
- (no number) Valleylab Reusable Handswitching Pencil: named in the summary without a submission number
- (no number) I.C. Medical Electrocautery Shroud: named in the summary without a submission number

## Most influential descendants
- K120454: Safeair Smoke Pencil, (2012), 8 descendants of its own
- K142538: LiNA SafeAir Smoke Pencil (2014), 5 descendants of its own
- K143145: SafeAir Smoke Pencil (2014), 4 descendants of its own
- K153679: Stryker Neptune E-SEP Smoke Evacuation Pencil (2016), 3 descendants of its own
- K160693: Neptune E-SEP Smoke Evacuation Pencil (2016), 2 descendants of its own

## Indications for use
The Telescoping 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 the procedure.

Source page: https://510kreport.com/device/K961616
Methodology: https://510kreport.com/methodology