# K971986: Valley Forge Bipolar Loop

- Pathway: 510(k) (Traditional)
- Applicant: Valley Forge Scientific Corp.
- Decided: Aug 26, 1997 after 89 days
- Product code: HGI (Electrocautery, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4120
- 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
Valley Forge bipolar loop electrodes are designed for electrosurgical excisions in a dry, infiltrated or wet field. Gynecological indications are as follows: * loop excisions of the cervix * cervical conizations * external anogenital lesions * large vaginal intraepithelial neoplastic lesions

Source page: https://510kreport.com/device/K971986
Methodology: https://510kreport.com/methodology