# K961097: Electrosurgical Cutting & Coagulation Device & Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Debusk Knitting Mills, Div. Deroyal Industries
- Decided: Jun 3, 1996 after 76 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) 3M: named in the summary without a submission number
- (no number) Birtcher: named in the summary without a submission number
- (no number) ValleyLab: named in the summary without a submission number

## Indications for use
The DeRoyal Grounding Pad Adapter is indicated for use whenever the ESU machine requires a grounding pad of the type provided by SurgiMate, or the connector on the SurgiMate pad 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/K961097
Methodology: https://510kreport.com/methodology