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Versapoint Electrosurgery System (Scuba)

by Ethicon Inc.

510(k) K994418

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK994418 Date24 Jan 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
HIH
FDA applicant
ETHICON, Inc.
Device class
Class II
Regulation
21 CFR Part 884.1690
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Versapoint Electrosurgery System (Scuba) is a hysteroscopic bipolar electrosurgical system. It is classified as a hysteroscope and accessories under FDA device classification.

The system received FDA 510(k) clearance (K994418) on January 24, 2000, and is classified as a Class II medical device. It is supplied as a reusable system for use in obstetrics and gynecology settings, with no indication of sterility, single-use status, MRI safety, sizes, or storage conditions provided in the data.

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Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Versapoint Electrosurgery System (Scuba) used for?

    The Versapoint Electrosurgery System (Scuba) is a hysteroscopic bipolar electrosurgical system intended for use in obstetrics and gynecology procedures, as indicated by its classification as a hysteroscope and accessories under FDA device classification and its advisory committee assignment to Obstetrics/Gynecology.

  • Is the Versapoint Electrosurgery System (Scuba) reusable or single-use?

    The system is supplied as a reusable system, meaning it is designed for multiple uses after appropriate reprocessing, as explicitly stated in the device data which notes it is supplied as a reusable system for use in obstetrics and gynecology settings.

  • What regulatory pathway was used for the Versapoint Electrosurgery System (Scuba)?

    The Versapoint Electrosurgery System (Scuba) received FDA 510(k) clearance under submission K994418 on January 24, 2000, and was determined to be substantially equivalent to a predicate device, which is the regulatory pathway for Class II medical devices like this hysteroscopic system.