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PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System PG3970BPS

by Cordis US Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20705032040034 UDI-DI Date28 Aug 2015ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System
Generic Name
Bare-metal biliary stent
Model / Ref / Catalog
PG3970BPS
Primary DI / UDI-DI
20705032040034
510(k) Number
FDA Product Code
FGE
GMDN Term
Bare-metal biliary stent
Device Class
Class II
Regulation Number
876.5010
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Bare-metal biliary stent

Cleared under the same submission (K033394)

Show all (12)

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No