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THUNDERBEAT Open Fine Jaw Type X TB-0009OFX

by Olympus Medical Systems Corporation

Ref N5768330

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

13 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170394577 Basic UDI-DI 04953170394577UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170394577 UDI-DI Date8 Jul 2020ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

13 recalls · 13 ongoing · FDA

  • 11 recalls, same reason

    • Ongoing Z-1003-2025 FDA Class II initiated 25 Nov 2024
    • Ongoing Z-1001-2025 FDA Class II initiated 25 Nov 2024
    • Ongoing Z-0994-2025 FDA Class II initiated 25 Nov 2024
    • Ongoing Z-0993-2025 FDA Class II initiated 25 Nov 2024
    • Ongoing Z-0998-2025 FDA Class II initiated 25 Nov 2024
    • Ongoing Z-0997-2025 FDA Class II initiated 25 Nov 2024
    • Ongoing Z-1000-2025 FDA Class II initiated 25 Nov 2024
    • Ongoing Z-1002-2025 FDA Class II initiated 25 Nov 2024
    • Ongoing Z-0999-2025 FDA Class II initiated 25 Nov 2024
    • Ongoing Z-0995-2025 FDA Class II initiated 25 Nov 2024
    • Ongoing Z-0996-2025 FDA Class II initiated 25 Nov 2024

    The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.

  • 2 recalls, same reason

    • Ongoing Z-0108-2024 FDA Class II initiated 12 Sep 2023
    • Ongoing Z-0109-2024 FDA Class II initiated 12 Sep 2023

    Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
THUNDERBEAT Open Fine Jaw TypeX TB-0009OFX EUDAMED
THUNDERBEAT Open Fine Jaw Type X GUDID
Generic Name
Endoscopic electrosurgical/ultrasonic surgical system instrument
Device Name
Thunderbeat
Model / Reference
N5768330 EUDAMED
TB-0009OFX GUDID
Primary DI / UDI-DI
04953170394577
Basic UDI-DI
B-04953170394577
FDA Product Code
GEI, LFL
EMDN Code
K02050109 Combined radiofrequency / ultrasonic surgery handpieces, single-use
GMDN Term
Endoscopic electrosurgical/ultrasonic surgical system instrument
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
Market of Registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N5768330
GUDID
TB-0009OFX
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K211838)

Show all (12)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

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

Other properties (19)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No