# K961087: Deroyal Surgical (Surgimate) Pencil Adapters

- Pathway: 510(k) (Traditional)
- Applicant: Debusk Knitting Mills, Div. Deroyal Industries
- Decided: May 16, 1996 after 58 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) ValleyLab: named in the summary without a submission number
- (no number) Weck: named in the summary without a submission number

## Indications for use
The DeRoyal Cautery Pencil Adapter is indicated for use whenever the ESU machine requires a Cautery Pencil of the type provided by SurgiMate, or the connector on the SurgiMate Pencil does not match the intended jack of the ESU machine but its use would make the electrical connection compatible.

Source page: https://510kreport.com/device/K961087
Methodology: https://510kreport.com/methodology