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THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm TB2-0545FC

by Olympus Medical Systems Corporation

Ref R5001011

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

4 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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number495317000068BR Basic UDI-DI 04953170440021UDI-DIDate2 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170440021 UDI-DI Date4 Dec 2025ListedStatusListed GUDID: 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

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-1854-2026 FDA Class II initiated 23 Mar 2026
    • Ongoing Z-1851-2026 FDA Class II initiated 23 Mar 2026
    • Ongoing Z-1853-2026 FDA Class II initiated 23 Mar 2026
    • Ongoing Z-1852-2026 FDA Class II initiated 23 Mar 2026

    Potential for detachment of a distal tip component of the device during use.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
THUNDERBEAT II Shears with Ultrasonic Mode, 5 mm, 20 cm TB2-0545FC EUDAMED
THUNDERBEAT II Shears with Ultrasonic Mode, 5mm, 45cm GUDID
Generic Name
Endoscopic electrosurgical/ultrasonic surgical system instrument
Device Name
Thunderbeat
Model / Ref / Catalog
R5001011, TB2-0545FC
Primary DI / UDI-DI
04953170440021
Basic UDI-DI
495317000068BR
510(k) Number
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
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
R5001011
GUDID
TB2-0545FC
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Cleared under the same submission (K252150)

Other devices from Olympus Medical Systems Corporation

See all devices from Olympus Medical Systems Corporation →

Properties

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

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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