# K962482: Scuba System

- Pathway: 510(k) (Traditional)
- Applicant: Gynecare, Inc.
- Decided: Nov 1, 1996 after 128 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
56 later devices descend from it; 3 cite it directly.
0 of 57 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) Erbotom Generator: named in the summary without a submission number
- (no number) Karl Storz Hysteroscopic Resectoscopy Accessories (electrodes): named in the summary without a submission number

## Most influential descendants
- K990628: Gyrus Endourology System (1999), 52 descendants of its own
- K030194: Xues-41 Endoscopic Electrosurgical Unit (2003), 49 descendants of its own
- K100816: PK Superpulse Sysem Generator Model 744000 (2010), 22 descendants of its own
- K110268: Forcetriad Electrosurgical Generator (2011), 16 descendants of its own
- K994166: Gyrus Endourology System: Axipolar Resectoscope Electrode (1999), 16 descendants of its own

## Recalls of this device
- Dec 16, 2004 · Not classified · Z-0493-05: Deformation of the Verspoint Hysteroscopic System Connector Cable hand grips when autoclaved causing possible non-sterile electrodes.

## Indications for use
The Scuba is intended to be used for tissue cutting, vaporization and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for excision of intrauterine myomas and polyps, lysis of intrauterine adhesions, and excision of uterine septa.

Source page: https://510kreport.com/device/K962482
Methodology: https://510kreport.com/methodology