Identifiers
- 510(k) Number
- K181864 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 Polaris RF Ablation System is a device intended for the creation of radiofrequency lesions in nervous tissue. It delivers controlled RF energy from the Polaris RF Generator to target tissues via the Polaris RF Probes for standard RF procedures or Polaris Cooled RF Probes for cooled RF procedures.
The system is supplied by Baylis Medical Company Inc. and is authorized under FDA 510(k) clearance with product code GXD. It is designed for use in neurology procedures and is regulated as a class II device. The system includes various probe models and is intended for single-use applications in clinical settings.
Frequently asked questions
What is the Polaris RF Ablation System used for?
The Polaris RF Ablation System is designed for creating radiofrequency lesions in nervous tissue. It delivers controlled RF energy from the generator to target tissues using either standard RF probes or cooled RF probes, depending on the procedure requirements.
How is the Polaris RF Ablation System supplied?
The system is supplied by Baylis Medical Company Inc. and includes various probe models designed for different RF procedures. It is intended for single-use applications in clinical settings, ensuring sterility and safety for each patient.
What is the regulatory status of the Polaris RF Ablation System?
The Polaris RF Ablation System is authorized under FDA 510(k) clearance with product code GXD. It is regulated as a class II device and was found to be substantially equivalent to predicate devices for neurology procedures.
What probe options are available with the Polaris RF Ablation System?
The system is compatible with both standard RF probes and Polaris Cooled RF Probes, allowing clinicians to choose the appropriate technology based on their specific procedural needs. Various probe models are available to accommodate different clinical applications.
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: Polaris RF Ablation System (K181864) — FDA 510(k) | Innolitics, K181864 FDA 510 (k) - Polaris RF Ablation System, PDF Baylis Medical Company Inc. January 2, 2019 May Tsai Team Leader ..., Polaris RF Ablation System 510(k) K181864 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181864 | Class II | Active |
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Manufacturer
- Manufacturer
- Baylis Medical Company Inc.
- FDA Applicant
- Baylis Medical Company, Inc.
Sources (1)
- FDA 510(k) K181864 24 fields · synced Sep 27, 2026