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Stopex-Condoms-

by Tropex Worldwide, Inc. 510(k)

Active United States

510(k) K834591

Overview

The Stopex Condoms are a type of condom, which is a device used for contraception. According to the device type and definition, it falls under the category of Obstetrics/Gynecology. The device has a regulation number of 884.5300 and is classified as a class 2 device.

The Stopex Condoms are supplied by Tropex Worldwide, Inc. and have been granted FDA 510(k) clearance, with a clearance type of Traditional and a decision description of Substantially Equivalent. The device has a product code of HIS and is registered with the FDA under various registration numbers, including 2084177 and 3003592318. The device is used in the medical specialty of Obstetrics/Gynecology.

AI-generated from registry data, 21 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK834591 Date4 Feb 1984ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HIS
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Questions

  • What is the Stopex Condoms device used for?

    The Stopex Condoms device is used for contraception, specifically for birth control, and falls under the category of Obstetrics/Gynecology.

  • What is the regulatory classification of the Stopex Condoms device?

    The Stopex Condoms device is classified as a class 2 device with a regulation number of 884.5300.

  • Has the Stopex Condoms device received FDA clearance?

    Yes, the Stopex Condoms device has been granted FDA 510(k) clearance with a clearance type of Traditional and a decision description of Substantially Equivalent.