# K971540: American Biosurgical Electrosurgical Monopolar Cable/Cord

- Pathway: 510(k) (Traditional)
- Applicant: American Biosurgical, Inc.
- Decided: Aug 14, 1997 after 108 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
{Y\GV\O PD[C\( CO\‘O : To *romsden elecical it grom o W s~ o- @WM

Source page: https://510kreport.com/device/K971540
Methodology: https://510kreport.com/methodology