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Multipurpose, Nephrostomy and Biliary Drainage Catheters

by Navilyst Medical, Inc.

510(k) K093392

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 · Abbreviated NumberK093392 Date31 Dec 2009ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0647-2012 FDA Unclassified (pre-2012) initiated 4 Feb 2011
    • Terminated Z-0648-2012 FDA Unclassified (pre-2012) initiated 4 Feb 2011

    Navilyst Medical, Inc. determined that the Exodus Standard Loop Biliary Drainage Catheters exhibited a rate of reported failures (catheter tip fragmentation) higher than anticipated.

    • Terminated Z-0015-2011 FDA Unclassified (pre-2012) initiated 24 May 2010

    One box containing five catheters did not complete the sterilization process prior to distribution.

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  • Withdrawn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
FGE
Device Class
Class II
Regulation
21 CFR Part 876.5010
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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