# K992901: Gynecare Versapoint G-Vap Electrode

- Pathway: 510(k) (Traditional)
- Applicant: Gynecare, Inc.
- Decided: Jan 18, 2000 after 141 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- 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) Scuba Electrosurgical System: named in the summary without a submission number

## Indications for use
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation. Excision of intrauterine myomas Excision of intrauterine polyps Lysis of intrauterine adhesions Incision of uterine septa Endometrial ablation

Source page: https://510kreport.com/device/K992901
Methodology: https://510kreport.com/methodology