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Sovereign Bipolar Instruments For Gynecology

by Aesculap, Inc.

510(k) K003608

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003608 Date20 Feb 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
HGI
Device Class
Class II
Regulation
21 CFR Part 884.4120
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Sovereign Bipolar Instruments For Gynecology are electrocautery devices designed to destroy tissue with high temperatures through contact with an electrically heated probe. These instruments are used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation in gynecological procedures.

The devices are manufactured by Aesculap, Inc. and are classified as Class II medical devices under product code HGI with special controls. They received FDA 510(k) clearance on February 20, 2001, with K number K003608. The instruments are regulated under section 884.4120 for gynecologic electrocautery and accessories.

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