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Ultracision Harmonic Scalpel Sharp Curved Blade/Fast Blade, Model Hf105
FDA 510(k)EUDAMEDU (US FDA 510(k))
510(k) K994280
Identifiers
- 510(k) Number
- K994280 FDA 510(k)
- FDA Product Code
- LFL FDA 510(k)
Classification
- Device Class
- U FDA 510(k)
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Ultracision Harmonic Scalpel Sharp Curved Blade/Fast Blade, Model Hf105 by Ethicon Endo-Surgery, Inc. — U — MDR, FDA_510K — listed in FDA 510(k), 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 | K994280 | U | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, Inc.
Sources (2)
- FDA 510(k) K994280 24 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced May 28, 2026