Identity
- Trade Name
- ClosureRFG™ EUDAMEDFDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- ClosureRFG Generator EUDAMEDGENERATOR RFG3 CLOSUREFAST FDA UDI
- Model / Reference
- RFG3 EUDAMEDFDA UDI
- Description
- GENERATOR RFG3 CLOSUREFAST FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00763000723316 EUDAMED10884521777545 FDA UDI
- Basic UDI-DI
- 0763000B00004077G EUDAMED
- 510(k) Number
- K141858 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K020399 DEVICES FOR SURGERY WITH RADIOFREQUENCY GENERATOR, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Percutaneous radio-frequency ablation system generator
ClosureRFG™ by Medtronic, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation system generator.
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Cleared under the same submission
K141858 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic, Inc.
Sources (2)
- FDA UDI cad5e9c1-df29-4033-9036-3477f42faa16 36 fields · synced Jul 13, 2026
- EUDAMED 26311840-6d92-4823-a03e-ddee8aaed3a4 61 fields · synced Jul 13, 2026