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Sterile Catherization Procedure Trays

by Welcon, Inc.

510(k) K830359

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

16 closed

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 · Traditional NumberK830359 Date17 Mar 1983ClearedStatusActive

Recalls

16 recalls · FDA

  • 16 recalls, same reason

    • Terminated Z-0493-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0491-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0498-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0499-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0494-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0505-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0500-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0501-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0490-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0504-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0503-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0492-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0497-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0502-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0495-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011
    • Terminated Z-0496-2012 FDA Unclassified (pre-2012) initiated 2 Sep 2011

    Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.

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  • Withdrawn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
KOD
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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