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Disposable Balloon Catheter B5-2Q

by Olympus Medical Systems Corporation 3 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

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 Number04953170454233 UDI-DI Date19 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Disposable Balloon Catheter
Generic Name
Gastrointestinal/tracheobronchial balloon catheter
Model / Ref / Catalog
B5-2Q, N6214940
Primary DI / UDI-DI
04953170454233
510(k) Number
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

Cleared under the same submission (K250409)

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