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Ultrasonic Scalpel System
FDA 510(k)FDA UDIEUDAMEDU (US FDA 510(k))
510(k) K212614Ref SC43CRef SC21C+Ref SC17S2Ref SC13C+Ref SC35ERef SC35CRef SC13ERef SC09SRef SC43ERef SC13CRef SC35C+Ref SC21E
Identity
- Trade Name
- Ultrasonic scalpel EUDAMEDSonicure FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system FDA UDI
- Device Name
- Ultrasonic scalpel EUDAMED
- Model / Reference
- SC35C+ EUDAMEDFDA UDISC13C+ EUDAMEDFDA UDISC21C+ EUDAMEDFDA UDISC43C EUDAMEDSC17S2 EUDAMEDSC35E EUDAMEDSC35C EUDAMEDSC13E EUDAMEDSC09S EUDAMEDSC43E EUDAMEDSC13C EUDAMEDSC21E EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16972304750473 EUDAMEDFDA UDI16972304750459 EUDAMEDFDA UDI16972304750466 EUDAMEDFDA UDI16972304751074 EUDAMED16972304755010 EUDAMED16972304755041 EUDAMED16972304751067 EUDAMED16972304755027 EUDAMED16972304754983 EUDAMED16972304755058 EUDAMED16972304751043 EUDAMED16972304755034 EUDAMED
- Basic UDI-DI
- 697230475000977 EUDAMED
- 510(k) Number
- FDA Product Code
- LFL FDA 510(k)FDA UDI
- EMDN Code
- Z12010801 ULTRASONIC SCALPEL EUDAMED
- GMDN Term
- Soft-tissue ultrasonic surgical system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU FDA 510(k)FDA UDI
- Market of Registration
- Slovenia EUDAMEDGreece EUDAMEDGermany EUDAMEDItaly EUDAMED
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Ethylene Oxide FDA UDI
Ultrasonic Scalpel System by Surgnova Healthcare Technologies (zhejiang) Co., Ltd. — U — MDR, FDA_510K — listed in FDA 510(k), FDA GUDID, EUDAMED
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
MDR
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | U | Active |
| FDA 510(k) | United States | FDA_510K | K212614 | U | Active |
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Manufacturer
Sources (16)
- FDA 510(k) K212614 24 fields · synced Jul 30, 2026
- FDA UDI fa1144ee-88b9-443d-8e05-cf53e8a26fc0 33 fields · synced May 29, 2026
- FDA UDI 7aead5f1-0947-4918-a791-7648b8272ac5 33 fields · synced May 30, 2026
- FDA UDI abdd92db-d40c-4809-94bb-7daa9463df6d 33 fields · synced May 30, 2026
- EUDAMED 16e1c63e-3048-4aaf-aae2-c261b59d1f8b 61 fields · synced Jul 9, 2026
- EUDAMED a53fe85c-eb6f-42ae-a097-d8fcf4c71b59 61 fields · synced Jul 9, 2026
- EUDAMED 5515b8c0-1086-4212-80e9-83e1e0f9f060 61 fields · synced Jul 9, 2026
- EUDAMED 5c85fff9-3cb0-4b43-9707-5419d410e7d3 61 fields · synced Jul 11, 2026
- EUDAMED b44afefc-6a09-44f8-81de-1e87cb2613ce 61 fields · synced Jul 13, 2026
- EUDAMED a8f3e57b-3dfd-4fac-a50a-6c48462f286c 61 fields · synced Jul 13, 2026
- EUDAMED b279f29a-3a10-4edd-8356-baed90f12914 61 fields · synced Jul 16, 2026
- EUDAMED 849f9e13-dbbe-4842-8617-c631fcd6bec1 61 fields · synced Jul 16, 2026
- EUDAMED 241b2533-ec60-4dee-ab57-e96ae6cd2b8f 61 fields · synced Jul 17, 2026
- EUDAMED 9cbd45e8-94f5-4438-add0-fdc2fbc35261 61 fields · synced Jul 19, 2026
- EUDAMED 31a6ec2d-e6ff-432f-9499-a5283dfcac5b 61 fields · synced Jul 25, 2026
- EUDAMED 556336d4-7036-4e2e-bd62-c204c8c0a141 61 fields · synced Jul 30, 2026