Identity
- Trade Name
- ThermiRF FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- Thermi Radio Frequency Generator FDA UDI
- Model / Reference
- ThermiRF FDA UDI
- Description
- Thermi Radio Frequency Generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817371020014 FDA UDI
- 510(k) Number
- K130689 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
Category: Percutaneous radio-frequency ablation system generator
ThermiRF by Thermi — 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
- Mygen™ RF Generator M-3004 — RF Medical Co., Ltd. · 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
Cleared under the same submission
K130689 also covers:
- (Certified) ThermiRF+ — Celling Biosciences
- Arvati — Celling Biosciences
- Thermi Disposable RF Electrode (Qty 1) — Celling Biosciences
- Thermi Disposable RF Electrode (Qty 5) — Celling Biosciences
- Thermi Disposable RF Electrode (Qty 5) — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
- Thermi Reusable RF Electrode — Celling Biosciences
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 |
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Manufacturer
- Manufacturer
- Thermi
Sources (1)
- FDA UDI 9b7cdba9-4870-4857-aec7-edde2867730c 34 fields · synced May 31, 2026