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Bronchovideoscope Bf-1TQ170

by Olympus Medical Systems Corporation

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

10 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04953170342943 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

10 recalls · 10 ongoing · FDA

  • 5 recalls, same reason

    • Ongoing Z-0063-2026 FDA Class I initiated 11 Sep 2025
    • Ongoing Z-0050-2026 FDA Class I initiated 11 Sep 2025
    • Ongoing Z-0053-2026 FDA Class I initiated 11 Sep 2025
    • Ongoing Z-0060-2026 FDA Class I initiated 11 Sep 2025
    • Ongoing Z-0049-2026 FDA Class I initiated 11 Sep 2025

    Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

    • Ongoing Z-0192-2024 FDA Class I initiated 12 Oct 2023

    There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope.

    • Ongoing Z-0327-2024 FDA Class II initiated 25 Sep 2023

    Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

    • Ongoing Z-2496-2023 FDA Class II initiated 27 Jul 2023

    Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

  • 2 recalls, same reason

    • Ongoing Z-2017-2023 FDA Class I initiated 8 Jun 2023
    • Ongoing Z-2015-2023 FDA Class I initiated 8 Jun 2023

    There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bronchovideoscope
Generic Name
Flexible video bronchoscope, reusable
Model / Reference
BF-1TQ170
Primary DI / UDI-DI
04953170342943
510(k) Number
FDA Product Code
NWB, EOQ
GMDN Term
Flexible video bronchoscope, reusable
Device Class
Class II
Regulation Number
876.1500, 874.4680
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K121959)

Show all (9)

Other devices from Olympus Medical Systems Corporation

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No