# K972008: Endoscopic Electrosurgical Instruments and Electrodes

- Pathway: 510(k) (Traditional)
- Applicant: European Surgical, Inc.
- Decided: Sep 19, 1997 after 112 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 no predicate by number.

## Indications for use
The Select-Sutter Electrosurgical Forceps and Electrodes are reusable Electrosurgical Forceps and Electrodes that have applications in laparoscopic, general, neurologic and thoracic procedures. The Forceps and Electrodes are designed to provide surgeons with an electrosurgical technique for coagulation.

Source page: https://510kreport.com/device/K972008
Methodology: https://510kreport.com/methodology