Identity
- Trade Name
- THUNDERBEAT 5 mm, 35 cm, Inline Grip FDA UDI
- Generic Name
- Endoscopic electrosurgical/ultrasonic surgical system instrument FDA UDI
- Model / Reference
- TB-0535IC FDA UDI
Identifiers
- Catalog Number
- N3810631 FDA UDI
- Primary DI / UDI-DI
- 04953170464973 FDA UDI
- 510(k) Number
- K111202 FDA UDI
- FDA Product Code
- GEI FDA UDIKNS 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 UDI876.4300 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
No
FDA UDI
Category: Endoscopic electrosurgical/ultrasonic surgical system instrument
THUNDERBEAT 5 mm, 35 cm, Inline Grip 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 Open Fine Jaw Type X — Olympus Medical Systems Corporation · Class II
- 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
Cleared under the same submission
K111202 also covers:
- Adapter for UHI-2/3 — Olympus Medical Systems Corporation
- Communication Cable 0.25m — Olympus Medical Systems Corporation
- Communication cable 10 m — Olympus Medical Systems Corporation
- Docking fixture — Olympus Medical Systems Corporation
- Footswitch for SONICBEAT — Olympus Medical Systems Corporation
- Footswitch for THUNDERBEAT — Olympus Medical Systems Corporation
- THUNDERBEAT 5 mm, 10 cm, Inline Grip — Olympus Medical Systems Corporation
- THUNDERBEAT 5 mm, 20 cm, Inline Grip — Olympus Medical Systems Corporation
- THUNDERBEAT 5 mm, 35 cm, Inline Grip — Olympus Medical Systems Corporation
- THUNDERBEAT 5 mm, 35 cm, Pistol Grip — Olympus Medical Systems Corporation
- THUNDERBEAT 5 mm, 45 cm, Inline Grip — Olympus Medical Systems Corporation
- THUNDERBEAT 5 mm, 45 cm, Inline Grip — 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 cc4e792f-8585-49cf-b93b-a507c6908d26 35 fields · synced Jun 6, 2026