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Electrosurgical generator ESG-410
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref WA91317JRef WA91327W
Identity
- Trade Name
- Electrosurgical generator ESG-410 EUDAMEDOlympus FDA UDI
- Generic Name
- Electrosurgical/ultrasonic surgical system generator FDA UDI
- Device Name
- Electrosurgical Generators - ESG-410 EUDAMEDElectrosurgical Generators - ESG-410 ARTUS EUDAMEDElectrosurgical generator ESG-410 FDA UDI
- Model / Reference
- WA91317J EUDAMEDWA91327W EUDAMEDFDA UDI
- Description
- Electrosurgical generator ESG-410 FDA UDI
Identifiers
- Catalog Number
- WA91327W FDA UDI
- Primary DI / UDI-DI
- 04042761087124 EUDAMED04042761087704 EUDAMEDFDA UDI
- Basic UDI-DI
- 40427611105759 EUDAMED4042761110845C EUDAMED
- 510(k) Number
- K231777 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010905 RADIOSURGICAL UNITS EUDAMEDZ12010880,Z12010905 EUDAMED
- GMDN Term
- Electrosurgical/ultrasonic surgical system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Electrosurgical generator ESG-410 by Olympus Winter & Ibe GmbH — Class IIb — 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 | 40427611105759 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Olympus Winter & Ibe GmbH
- EUDAMED SRN
- DE-MF-000006729
Sources (3)
- EUDAMED 84d4b9c3-97b9-4883-b7fb-e189bf1541de 61 fields · synced Oct 6, 2026
- EUDAMED 8876376e-03ac-47eb-bb8e-530d9dd5fdec 61 fields · synced May 18, 2026
- FDA UDI 85ea076d-b927-4a11-a948-adce6ef46c1d 36 fields · synced May 27, 2026