Identity
- Trade Name
- ULTRASONIC BIPOLAR GENERATOR FDA UDI
- Generic Name
- Electrosurgical/ultrasonic surgical system generator FDA UDI
- Model / Reference
- USG-410 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170406881 FDA UDI
- 510(k) Number
- K211838 FDA UDI
- FDA Product Code
- GEI FDA UDILFL FDA UDI
- GMDN Term
- Electrosurgical/ultrasonic surgical system generator 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical/ultrasonic surgical system generator
Ultrasonic Bipolar Generator by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrosurgical/ultrasonic surgical system generator.
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- Handlike — Hunan Handlike Minimally Invasive Surgery Co., Ltd. · U
- Varicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 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 8a7a5b0a-76ad-4b0e-97b0-82cfe84c139a 34 fields · synced May 30, 2026