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Hsg Tray

by Unimar, Inc.

510(k) K920803

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

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)SEKD Traditional NumberK920803 Date19 Oct 1992ClearedStatusActive

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2136-2025 FDA Class II initiated 11 Jun 2025
    • Ongoing Z-2135-2025 FDA Class II initiated 11 Jun 2025
    • Ongoing Z-2137-2025 FDA Class II initiated 11 Jun 2025

    The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the iodine pouches as sterile.

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  • Withdrawn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
HIB
Device Class
Class II
Regulation
21 CFR Part 884.4530
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SEKD

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