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Palmaz Genesis Transhepatic Billary Stent and Delivery System

by Cordis Corp.

510(k) K010411

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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)SESU Abbreviated NumberK010411 Date27 Aug 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0567-04 FDA Unclassified (pre-2012) initiated 26 Sep 2003 on shared 510(k) K010411

    A packaging defect may compromise the device's sterility barrier.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
SESU

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