# K972562: Bipolar Electrosurgical Pencil, Straight and Angled

- Pathway: 510(k) (Traditional)
- Applicant: Electroscope, Inc.
- Decided: Jan 16, 1998 after 191 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
The Bipolar Electrosurgical Pencil is a device designed to be used in procedures involving cutting and coagulation of the soft body tissue.

Source page: https://510kreport.com/device/K972562
Methodology: https://510kreport.com/methodology