# K994418: Versapoint Electrosurgery System (Scuba)

- Pathway: 510(k) (Special)
- Applicant: ETHICON, Inc.
- Decided: Jan 24, 2000 after 26 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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
- (no number) Versapoint Electrosurgery G-VAP Electrode Accessory: named in the summary without a submission number

## Most influential descendants
- K111751: Versapoint II Bipolar Electrosurgery Generator, Versapoint II 44MM Angled Loop Electrode, Versapoint II Footswitch, Vers (2011), 1 descendant of its own
- K122983: Ksea Bipolar Electrode (2013), 0 descendants of its own

## 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 intrauterine adhesions Incision of uterine septa Endometrial ablation

Source page: https://510kreport.com/device/K994418
Methodology: https://510kreport.com/methodology