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Disposable Balloon Catheter B5-2Q

by Olympus Medical Systems Corporation GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170463754 UDI-DIDate25 Mar 2024ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0961-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0964-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0963-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0965-2021 FDA Class II initiated 4 Jan 2021
    • Terminated Z-0962-2021 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.

Specification

GUDID

Trade Name
Disposable Balloon Catheter
Generic Name
Gastrointestinal/tracheobronchial balloon catheter
Model / Ref / Catalog
B5-2Q, N6214971
Primary DI / UDI-DI
04953170463754
FDA Product Code
FGE
GMDN Term
Gastrointestinal/tracheobronchial balloon catheter
Device Class
Class II
Regulation Number
876.5010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Gastrointestinal/tracheobronchial balloon catheter

Cleared under the same submission (K962925)

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