# K961647: Deroyal Industries, Inc. Electrosurgical Cautery Pencil

- Pathway: 510(k) (Traditional)
- Applicant: Deroyal Industries, Inc.
- Decided: Oct 8, 1996 after 161 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.
No later device cites it as a predicate yet.
0 of 1 device 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) DeBusk Technology Corporation: named in the summary without a submission number

## Indications for use
The DeRoyal Cautery Pencil is indicated for use whenever an electrosurgical procedure requires the removal of tissue or the control of bleeding by either cutting or coagulation.

Source page: https://510kreport.com/device/K961647
Methodology: https://510kreport.com/methodology