# K040302: Versapoint Resectoscopic System

- Pathway: 510(k) (Special)
- Applicant: Gynecare, A Div. of Ethicon, Inc.
- Decided: Mar 9, 2004 after 29 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) VERSAPOINT* Electrosurgery System (SCUBA): 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, and septa, and benign conditions requiring endometrial ablation. - Excision of intrauterine myomas - Excision of intrauterine polyps - Lysis of irtrauterine adhesions - Incision of uterine septa - Endometrial ablation

Source page: https://510kreport.com/device/K040302
Methodology: https://510kreport.com/methodology