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INVIGRA

by Indus Medicare, Ltd. 4 variants

510(k) K020223

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 · Abbreviated NumberK020223 Date4 Mar 2002ClearedStatusActive

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  • Withdrawn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
HIS
FDA applicant
Indus Medicare , Ltd.
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

INVIGRA is a condom classified as an Obstetrics/Gynecology device under product code HIS. It is a Class 2 medical device that received FDA 510(k) clearance as substantially equivalent through an abbreviated review process.

The device was manufactured by Indus Medicare, Ltd. and received FDA clearance under K020223 on March 4, 2002. It is regulated under regulation number 884.5300 and is intended for use as a barrier contraceptive.

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