Identity
- Trade Name
- RF ABLATION SYSTEM V-1000 FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- The RF Ablation System V-1000 is a microprocessor-based generator. This generator provides up to 140 W of RF energy to be used for coagulation & ablation of vessel, tissue and bone. FDA UDI
- Model / Reference
- V-1000 FDA UDI
- Description
- The RF Ablation System V-1000 is a microprocessor-based generator. This generator provides up to 140 W of RF energy to be used for coagulation & ablation of vessel, tissue and bone. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809295147030 FDA UDI
- 510(k) Number
- K180999 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Percutaneous radio-frequency ablation system generator 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
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 226 Millimeter FDA UDIDepth — 391 Millimeter FDA UDIWidth — 322 Millimeter FDA UDIWeight — 13 Kilogram FDA UDI
Category: Percutaneous radio-frequency ablation system generator
Rf Ablation System V-1000 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 system generator.
- OneRF Ablation System — NEUROONE MEDICAL TECHNOLOGIES CORP. · Class II
- ATTIVA — ITALIAN ENGINEERING SRL · Class II
- OsteoCool™ RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC. · Class II
- Maestro 4000™ Controller — Boston Scientific · Class III
- SmartAblate™ System CoolFlow® Pump Cable — Stockert GmbH · Class III
- InSeal Sealer/Divider — Innolcon Medical Technology (Suzhou) Co., Ltd. · Class IIb
- Electrosurgical Pencil, Button Switch — DEROYAL INDUSTRIES, INC. · Class IIb
- OsteoCool™ 2.0 RF Ablation System — MEDTRONIC SOFAMOR DANEK, INC. · 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.
- 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.
- 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 3d4f8560-35de-4b1c-8c58-b912c885e9aa 37 fields · synced Jun 6, 2026