# K111751: Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop Electrode, Versapoint II Footswitch, Vers

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Dec 2, 2011 after 163 days
- Product code: HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962482 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962482: Scuba System, Gynecare, Inc. (1996) Summary page 1.
- K994418: Versapoint Electrosurgery System (Scuba), ETHICON, Inc. (2000) Summary page 1.

## Most influential descendants
- K122983: Ksea Bipolar Electrode (2013), 0 descendants of its own

## Indications for use
The GYNECARE VERSAPOINTTM 11 Bipolar Electrosurgery System is intended for use in tissue cutting, removal and desiccation as requited or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiting endometrial ablation. Procedures include: * Excision of intrauterine myomas * Excision of intrauterine polyps * Lysis of intrauterine adhesions * Incision of uterine septa * Endometrial ablation

Source page: https://510kreport.com/device/K111751
Methodology: https://510kreport.com/methodology