Identity
- Trade Name
- Sonicure FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system FDA UDI
- Model / Reference
- SC100E FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972304750315 FDA UDI
- 510(k) Number
- K212614 FDA UDI
- FDA Product Code
- LFL FDA UDI
- GMDN Term
- Soft-tissue ultrasonic surgical system FDA UDI
Classification
- Device Class
- U 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: Soft-tissue ultrasonic surgical system
Sonicure by Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212614 also covers:
- Sonicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Sonicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Sonicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Varicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
- Varicure — Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
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 U | Pending data |
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Manufacturer
Sources (1)
- FDA UDI 6d15e18f-38d6-4aa2-83c5-e32ffeb3b15a 33 fields · synced May 30, 2026