Identity
- Trade Name
- THUNDERBEAT Open Fine Jaw Type X FDA UDI
- Generic Name
- Endoscopic electrosurgical/ultrasonic surgical system instrument FDA UDI
- Model / Reference
- TB-0009OFX FDA UDI
Identifiers
- Catalog Number
- N5768340 FDA UDI
- Primary DI / UDI-DI
- 04953170435829 FDA UDI
- 510(k) Number
- K211838 FDA UDI
- FDA Product Code
- GEI FDA UDILFL FDA UDI
- GMDN Term
- Endoscopic electrosurgical/ultrasonic surgical system instrument FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic electrosurgical/ultrasonic surgical system instrument
THUNDERBEAT Open Fine Jaw Type X by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic electrosurgical/ultrasonic surgical system instrument.
- THUNDERBEAT 5 mm, 45 cm, Pistol Grip — Olympus Medical Systems Corporation · Class II
- THUNDERBEAT Open Fine Jaw — Olympus Medical Systems Corporation · U
- THUNDERBEAT 5 mm, 35 cm, Inline Grip — Olympus Medical Systems Corporation · Class II
- THUNDERBEAT 5 mm, 35 cm, Pistol Grip — Olympus Medical Systems Corporation · Class II
- THUNDERBEAT 5 mm, 10 cm, Inline Grip — Olympus Medical Systems Corporation · U
- THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S — Olympus Medical Systems Corporation · U
- THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S — Olympus Medical Systems Corporation · U
- THUNDERBEAT 5 mm, 45 cm, Pistol Grip — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K211838 also covers:
- SONICBEAT 5 mm, 10 cm, Inline Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 10 cm, Inline Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 20 cm, Front-actuated Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 35 cm, Front-actuated Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 35 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 35 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 45 cm, Front-actuated Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 45 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 45 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT Footswitch Connector — Olympus Medical Systems Corporation
- SONICBEAT Transducer — Olympus Medical Systems Corporation
- THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S — Olympus Medical Systems Corporation
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI 3e07f3a5-0cff-4fb3-934f-f7b8fd87198b 35 fields · synced Jun 6, 2026