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Gynescope Laparoscopic Forceps

by Gynescope Corp.

510(k) K902657

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 · Traditional NumberK902657 Date19 Sep 1990ClearedStatusActive

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  • Withdrawn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
HET
Device Class
Class II
Regulation
21 CFR Part 884.1720
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Gynescope Laparoscopic Forceps is a laparoscopic instrument used for grasping, manipulating, and dissecting tissues during laparoscopic procedures. It is designed for use in obstetrics and gynecology surgeries.

The device is supplied as a Class II medical device with FDA 510(k) clearance K902657, granted on September 19, 1990. It is manufactured by Gynescope Corp. and is not specified as single-use or reusable in the provided data.

Other devices from Gynescope Corp.

See all devices from Gynescope Corp. →

Questions

AI-generated answers, 6 Oct 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 Gynescope Laparoscopic Forceps used for?

    The Gynescope Laparoscopic Forceps is a specialized instrument designed for grasping, manipulating, and dissecting tissues during laparoscopic procedures, specifically in obstetrics and gynecology surgeries.

  • Is the Gynescope Laparoscopic Forceps single-use or reusable?

    The device data does not specify whether the Gynescope Laparoscopic Forceps is intended for single-use or reusable purposes. This information should be confirmed with the manufacturer or product instructions.

  • What is the regulatory status of the Gynescope Laparoscopic Forceps?

    The Gynescope Laparoscopic Forceps is a Class II medical device with FDA 510(k) clearance K902657, granted on September 19, 1990, and is manufactured by Gynescope Corp. It is substantially equivalent to other devices in its product code category HET.

  • How is the Gynescope Laparoscopic Forceps supplied?

    The device is supplied as a Class II medical device with FDA 510(k) clearance. The specific packaging and sterilization details are not provided in the available data.