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Gynex Endospeculum

by Gynex Corporation

510(k) K980237

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 NumberK980237 Date8 Apr 1998ClearedStatusActive

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  • Withdrawn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
KNA
FDA applicant
Gynex Corp.
Device class
Class II
Regulation
21 CFR Part 884.4530
Advisory committee
Obstetrics/Gynecology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 Gynex Endocervical Speculum is a specialized obstetric-gynecologic instrument designed for use in gynecological examinations. It is a manual device intended to provide access to the cervix for diagnostic or procedural purposes.

This stainless steel speculum is supplied sterile and is intended for single use. It is available in a 10" length with a 4mm tip opening. The device is not MRI safe and should be stored in a dry environment until use.

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Questions

AI-generated answers, 26 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 Gynex Endocervical Speculum used for?

    It is a specialized manual instrument designed to provide access to the cervix for diagnostic or procedural purposes during gynecological examinations.

  • Is the Gynex Endocervical Speculum sterile?

    Yes, the device is supplied sterile and is intended for single use, ensuring a hygienic examination environment.

  • What are the specifications of the Gynex Endocervical Speculum?

    It is a stainless steel device available in a 10-inch length with a 4mm tip opening. It is not MRI safe and should be stored in a dry environment until use.

  • How is the Gynex Endocervical Speculum supplied?

    The device is supplied sterile and is intended for single use, meaning it should be disposed of after one examination.