Identifiers
- 510(k) Number
- K232632 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 Racz Neurostat RF Generator is a radiofrequency (RF) lesion generator designed for creating controlled thermal lesions in neural tissue. It operates within the peripheral nervous system to disrupt nerve pathways, primarily for pain management procedures. The device delivers precise radiofrequency energy to targeted areas, enabling clinicians to ablate specific nerves or tissues as part of interventional pain therapies.
This device is supplied as a reusable medical instrument and is intended for use in clinical settings by trained professionals. It requires compatibility with Epimed RF probes and cannulas for procedural application. The Racz Neurostat RF Generator is classified as a Class II medical device under FDA regulations (product code GXD) and has received FDA 510(k) clearance through the Traditional pathway. No specific sterility or MRI safety information is provided in the regulatory data, and its use adheres to standard aseptic practices for reusable devices.
Frequently asked questions
What is the Racz Neurostat RF Generator used for?
The Racz Neurostat RF Generator is designed for creating controlled thermal lesions in neural tissue within the peripheral nervous system. It is primarily used to disrupt nerve pathways as part of interventional pain therapies, helping clinicians manage chronic pain by ablating specific nerves or tissues.
Is the Racz Neurostat RF Generator reusable or single-use?
The Racz Neurostat RF Generator is supplied as a reusable medical instrument. It is intended for use in clinical settings by trained professionals and must adhere to standard aseptic practices for reusable devices, as no specific sterility information is provided.
What compatibility requirements does the Racz Neurostat RF Generator have?
The Racz Neurostat RF Generator requires compatibility with Epimed RF probes and cannulas for procedural application. These components work together to ensure precise delivery of radiofrequency energy during pain management procedures.
How is the sterility of the Racz Neurostat RF Generator ensured?
The device is classified as reusable, so sterility is ensured through standard clinical aseptic practices. Since no specific sterility information is provided in the regulatory data, it is critical to follow manufacturer guidelines and institutional protocols for cleaning, disinfection, and sterilization to maintain safety and efficacy.
What regulatory pathway was followed for the Racz Neurostat RF Generator?
The Racz Neurostat RF Generator received FDA 510(k) clearance through the Traditional pathway. It is classified as a Class II medical device under FDA regulations with product code GXD, and it was reviewed by the Neurology Advisory Committee (NE).
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: PDF Epimed International ℅ Robert Packard President, Medical Device Acade, K232632 FDA 510 (k) - Racz Neurostat RF Generator, Racz Neurostat RF Generator (K232632) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232632 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Epimed International
Sources (1)
- FDA 510(k) K232632 24 fields · synced Oct 1, 2026