Identity
- Trade Name
- RFT Electrode FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
- Device Name
- The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit. FDA UDI
- Model / Reference
- RFTP-0707N FDA UDI
- Description
- The RFT electrode is sterile single use mono-polar electrode for electrosurgical unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809559960061 FDA UDI
- 510(k) Number
- K180999 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Catheter Working Length — 7 Millimeter FDA UDICatheter Length — 7 Centimeter FDA UDI
Category: Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar
RFT Electrode by RF Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar.
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- ElectrodeCRF — Cambridge Interventional LLC · Class II
- StarBurst — NAVILYST MEDICAL, INC. · Class II
- Soloist™ — Boston Scientific · Class II
Cleared under the same submission
K180999 also covers:
- 2-Pin Dispersive Electrode cable — RF Medical Co., Ltd.
- Cooling pump — RF Medical Co., Ltd.
- Dual Foot Switch — RF Medical Co., Ltd.
- RF ABLATION SYSTEM V-1000 — RF Medical Co., Ltd.
- RFT Electrode — RF Medical Co., Ltd.
- RFT Electrode — RF Medical Co., Ltd.
- RFT Electrode — RF Medical Co., Ltd.
- RFT Electrode — RF Medical Co., Ltd.
- RFT Electrode — RF Medical Co., Ltd.
- Single channel Foot Switch — RF Medical Co., Ltd.
- THYBLATE™ — RF Medical Co., Ltd.
- THYBLATE™ — RF Medical Co., Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- RF Medical Co., Ltd.
Sources (1)
- FDA UDI c03e6923-8ac9-414f-bb2e-1100910282cd 37 fields · synced Jun 8, 2026