# K081634: Conmed Goldvac Integrated Smoke Evacuation Pencil

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Jun 25, 2008 after 14 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 K791137 (1979). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982309: Smoke Evacuation Attachment 130XXX TBD, Conmedcorp (1998) Summary page 1.
- K791137: Single Use Monopolar Hand Control Pencil, Davol, Inc. (1979) Summary page 1.

## 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 GoldVac pencils, when used with an effective smoke evacuation system, removes smoke plume from the surgical site. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

Source page: https://510kreport.com/device/K081634
Methodology: https://510kreport.com/methodology