Relievant Medsystems RF Generator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K171143 FDA 510(k)
- FDA Product Code
- GXD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4400 FDA 510(k)
- Regulation Number
- 882.4400 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Relievant Medsystems RF Generator is a microcontrolled, AC-powered, bipolar radiofrequency generator that delivers RF energy to targeted sites for thermal coagulation of basivertebral nerves. It is used in conjunction with Relievant INTRACEPT RF probes and monitors power, temperature, and impedance at the treatment site to control energy delivery.
This device is supplied as a reusable unit and is regulated under FDA 510(k) clearance with product code GXD. It is classified as a Class II medical device for Generator, Lesion, Radiofrequency in the medical specialty of Neurology. The device is intended for use in clinical settings with appropriate authorization.
Frequently asked questions
What is the purpose of the Relievant Medsystems RF Generator?
The Relievant Medsystems RF Generator is a microcontrolled, AC-powered device that delivers radiofrequency energy to targeted sites for thermal coagulation of basivertebral nerves. It monitors power, temperature, and impedance at the treatment site to control energy delivery.
How is the Relievant Medsystems RF Generator supplied and is it reusable?
The device is supplied as a reusable unit designed for clinical settings with appropriate authorization. It is intended for repeated use in medical procedures requiring precise radiofrequency energy delivery.
What is the regulatory classification of the Relievant Medsystems RF Generator?
The device is regulated under FDA 510(k) clearance with product code GXD. It is classified as a Class II medical device for Generator, Lesion, Radiofrequency in the medical specialty of Neurology.
What components work with the Relievant Medsystems RF Generator?
The RF Generator is used in conjunction with Relievant INTRACEPT RF probes. This combination allows for precise delivery of radiofrequency energy to targeted sites while monitoring critical parameters during treatment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Relievant Medsystems RF Generator (K171143) — FDA 510 (k) | Innolitics, Relievant Medsystems RF Generator 510(k) K171143 - FDA.report, Relievant Medsystems RF Generator — FDA K171143
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171143 | Class II | Active |
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Manufacturer
- Manufacturer
- Relievant Medsystems
Sources (1)
- FDA 510(k) K171143 24 fields · synced Sep 22, 2026