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Single Use 3-Lumen Extraction Balloon V B-V443Q-A

by Olympus Medical Systems Corporation 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170279553 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0967-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0966-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0968-2021 FDA Class II initiated 4 Jan 2021

    Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Single Use 3-Lumen Extraction Balloon V
Generic Name
ERCP catheter, balloon, non-electrical, stone-retrieval
Model / Reference
B-V443Q-A
Primary DI / UDI-DI
04953170279553
510(k) Number
FDA Product Code
LQR, FGE
GMDN Term
ERCP catheter, balloon, non-electrical, stone-retrieval
Device Class
Class II
Regulation Number
876.5010
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K091495)

Show all (10)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Implantable: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No