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Sterile Urethral Catheter Procedure Kits

by Superior Healthcare Group, Inc.

510(k) K903340

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

7 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)SESD Substantially Equivalent — Deferred · Traditional NumberK903340 Date4 Oct 1990ClearedStatusActive

Recalls

7 recalls · 7 ongoing · FDA

    • Ongoing Z-1045-2024 FDA Class I initiated 4 Dec 2023

    Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

  • 6 recalls, same reason

    • Ongoing Z-0360-2023 FDA Class II initiated 1 Nov 2022
    • Ongoing Z-0356-2023 FDA Class II initiated 1 Nov 2022
    • Ongoing Z-0361-2023 FDA Class II initiated 1 Nov 2022
    • Ongoing Z-0359-2023 FDA Class II initiated 1 Nov 2022
    • Ongoing Z-0357-2023 FDA Class II initiated 1 Nov 2022
    • Ongoing Z-0358-2023 FDA Class II initiated 1 Nov 2022

    Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention

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  • Withdrawn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
FCM
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESD Substantially Equivalent — Deferred

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