# K940909: Electrosurgical Monopolar Handswitching Pencil W/Removable Blade

- Pathway: 510(k) (Traditional)
- Applicant: Debusk Technology Corp.
- Decided: Mar 30, 1994 after 35 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K132199: Deroyal Electrosurgical Pencil, Rocker Style Without Holster, Deroyal Electrosurgical Pencil, Button Style Without Holst (2013), 0 descendants of its own

## Recalls of this device
- Apr 23, 2018 · Class II · Z-1583-2018: Non-sterile product was packaged inside a case that was labeled as sterile.

Source page: https://510kreport.com/device/K940909
Methodology: https://510kreport.com/methodology