# K791137: Single Use Monopolar Hand Control Pencil

- Pathway: 510(k) (Traditional)
- Applicant: Davol, Inc.
- Decided: Jul 24, 1979 after 36 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K081634: Conmed Goldvac Integrated Smoke Evacuation Pencil (2008), 9 descendants of its own
- 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

## Recalls of this device
- Mar 29, 2010 · Not classified · Z-1566-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.
- Mar 29, 2010 · Not classified · Z-1563-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.
- Mar 29, 2010 · Not classified · Z-1567-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.
- Mar 29, 2010 · Not classified · Z-1568-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.
- Mar 29, 2010 · Not classified · Z-1572-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.
- Mar 29, 2010 · Not classified · Z-1569-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.
- Mar 29, 2010 · Not classified · Z-1564-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.
- Mar 29, 2010 · Not classified · Z-1570-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.
- Mar 29, 2010 · Not classified · Z-1573-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.
- Mar 29, 2010 · Not classified · Z-1562-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.
- Mar 29, 2010 · Not classified · Z-1571-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.
- Mar 29, 2010 · Not classified · Z-1565-2010: Electrosurgical pencil may remain activated or self activate after power switch is released.

Source page: https://510kreport.com/device/K791137
Methodology: https://510kreport.com/methodology