Identity
- Trade Name
- N/A FDA UDIDUALTO Energy System FDA UDI
- Generic Name
- Foot-switch, electrical FDA UDI
- Device Name
- Energy Footswitch EUDAMEDFootswitch G11 EUDAMEDFoot Switch G11 FDA UDIEnergy Double Footswitch FDA UDI
- Model / Reference
- FSW11 EUDAMEDFDA UDIETHEF2 EUDAMEDFDA UDI
- Description
- Foot Switch G11 FDA UDIEnergy Double Footswitch FDA UDI
Identifiers
- Catalog Number
- FSW11 FDA UDIETHEF2 FDA UDI
- Primary DI / UDI-DI
- 20705036013898 EUDAMEDFDA UDI20705036038396 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705036a000196T EUDAMED
- Direct Marketing DI
- 10705036013891 EUDAMED10705036038399 EUDAMED
- 510(k) Number
- K243067 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010980 ELECTROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Foot-switch, electrical FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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 UDIFDA UDI
Serial Number
No
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Energy Footswitch by Ethicon Endo-Surgery, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0705036a000196T | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Endo-Surgery, LLC
- EUDAMED SRN
- US-MF-000013107
- Authorised Representative
- Johnson & Johnson Medical GmbH DE-AR-000007712
Sources (4)
- EUDAMED 00c8588f-fc3e-41f6-8500-4a2a84111351 61 fields · synced Jul 30, 2026
- FDA UDI ef337d98-1a77-4189-aed9-f1434a55aec0 36 fields · synced May 24, 2026
- FDA UDI 5e4b362a-4fc4-4d43-8b52-c79b8d49bbdd 37 fields · synced May 30, 2026
- EUDAMED 72a60397-c61c-42c9-9f13-8ca6a1277303 61 fields · synced Jul 30, 2026