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Cordis Palmaz Genesis Transhepatic Billary Stent on Opta Pro .035 Delivery System

by Cordis Corp.

510(k) K033394

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 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)SESU Special NumberK033394 Date22 Dec 2003ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1363-2022 FDA Class II initiated 20 May 2022

    Potential for stent dislodgement and associated failures related to two specific sizes of the device.

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  • Withdrawn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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