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Urological Catheter

by Apogee, Inc.

510(k) K992137

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 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 NumberK992137 Date3 Sep 1999ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-2392-2008 FDA Unclassified (pre-2012) initiated 17 Jul 2008
    • Terminated Z-2391-2008 FDA Unclassified (pre-2012) initiated 17 Jul 2008
    • Terminated Z-2390-2008 FDA Unclassified (pre-2012) initiated 17 Jul 2008
    • Terminated Z-2393-2008 FDA Unclassified (pre-2012) initiated 17 Jul 2008
    • Terminated Z-2394-2008 FDA Unclassified (pre-2012) initiated 17 Jul 2008

    Due to a package seal defect the catheter tip may have been inadvertently cut which could cause trauma to the urethra upon use. Also the sterility of the product could be compromised.

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  • Withdrawn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

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