# K132199: Deroyal Electrosurgical Pencil, Rocker Style Without Holster, Deroyal Electrosurgical Pencil, Button Style Without Holst

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Oct 3, 2013 after 79 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 K940909 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940909: Electrosurgical Monopolar Handswitching Pencil W/Removable Blade, Debusk Technology Corp. (1994) Summary page 1.

## Indications for use
The DeRoyal Electrosurgical Pencil is intended to be used to remove tissue and control bleeding by use of high frequency electrical current. The pencil can be used during electrosurgical procedures for both cutting and coagulation.

Source page: https://510kreport.com/device/K132199
Methodology: https://510kreport.com/methodology