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Harmonic Focus Shears + Adaptive Tissue Technology
FDA 510(k)FDA UDIEUDAMEDU (US FDA 510(k))
510(k) K133314Ref HAR745Ref HP054Ref HARH23Ref HAR736
Identity
- Trade Name
- Harmonic EUDAMEDFDA UDIHarmonic ACE FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDISoft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
- Device Name
- Harmonic Hand Piece EUDAMEDFDA UDIHARMONIC 700 Shears EUDAMEDHARMONIC ACE+7 Shears EUDAMEDHarmonic 700 Shears, Advanced Hemostasis FDA UDIHarmonic ACE +7 Shears Advanced Hemostasis 5mm Diameter 23cm Shaft length For Use With Gray Hand Piece Only FDA UDI
- Model / Reference
- HP054 EUDAMEDFDA UDIHAR736 EUDAMEDFDA UDIHAR745 EUDAMEDFDA UDIHARH23 EUDAMEDFDA UDI
- Description
- Harmonic Hand Piece FDA UDIHarmonic 700 Shears, Advanced Hemostasis FDA UDIHarmonic ACE +7 Shears Advanced Hemostasis 5mm Diameter 23cm Shaft length For Use With Gray Hand Piece Only FDA UDI
Identifiers
- Catalog Number
- HP054 FDA UDIHAR736 FDA UDIHAR745 FDA UDIHARH23 FDA UDI
- Primary DI / UDI-DI
- 20705036002144 EUDAMEDFDA UDI10705036035770 EUDAMEDFDA UDI10705036035787 EUDAMEDFDA UDI10705036014676 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000797D EUDAMED0705036a000096Q EUDAMED0705036a000146H EUDAMED
- Direct Marketing DI
- 10705036002147 EUDAMED
- 510(k) Number
- K133314 FDA 510(k)
- FDA Product Code
- LFL FDA 510(k)FDA UDI
- EMDN Code
- K0202010601,K0202010602 EUDAMEDZ12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Soft-tissue ultrasonic surgical system handpiece, reusable FDA UDISoft-tissue ultrasonic surgical system handpiece tip, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDU FDA 510(k)FDA UDI
- Market of Registration
- Belgium 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
No
EUDAMEDFDA UDIEUDAMEDFDA UDI
Single Use
No
FDA UDIFDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMEDEUDAMED
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
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDIFDA UDI
Manufacturing Date
No
FDA UDI
Harmonic Focus Shears + Adaptive Tissue Technology by Ethicon Endo-Surgery, LLC — 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 | K133314 | U | Active |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
Sources (9)
- FDA 510(k) K133314 24 fields · synced Jul 20, 2026
- FDA UDI c1402c1d-3dd0-4c30-ac9a-cf061dca8f20 36 fields · synced May 30, 2026
- FDA UDI 28d2dfb1-fdaa-4751-843d-84b25795d8f5 36 fields · synced May 30, 2026
- FDA UDI 81192c76-0420-49c2-9ac2-3c4b678ded48 36 fields · synced May 30, 2026
- FDA UDI 04fbfc8a-e957-466a-89a4-92ffc8b18e49 36 fields · synced May 30, 2026
- EUDAMED 8c51657e-47a7-4b65-ba54-bfeb8988b034 61 fields · synced Jul 10, 2026
- EUDAMED ae3299f6-70b9-4c5b-9236-a38fd115b695 61 fields · synced Jul 12, 2026
- EUDAMED d15374fa-1661-40c2-b7eb-dbae584bedc5 61 fields · synced Jul 14, 2026
- EUDAMED 959c00a6-c3c6-4708-8088-f8ce2d077674 61 fields · synced Jul 20, 2026