Identifiers
- 510(k) Number
- K222032 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Neuromark System is a medical device intended for the application of radiofrequency energy to create lesions in mucosal tissue. It is designed for use in otolaryngological, or ear, nose and throat, procedures for patients with chronic rhinitis.
This system is authorized under FDA 510(k) clearance K222032. It is intended for use in otorhinolaryngology surgery for the creation of radiofrequency lesions.
Frequently asked questions
What is the primary clinical application of the Neuromark System?
The Neuromark System is specifically intended for use in otolaryngological, or ear, nose and throat, surgical procedures. It is designed to apply radiofrequency energy to create lesions in mucosal tissue for patients suffering from chronic rhinitis.
What is the regulatory status of the Neuromark System?
The Neuromark System has received FDA 510(k) clearance under the submission number K222032. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.
Who is the manufacturer of the Neuromark System?
The Neuromark System is manufactured by Neurent Medical, which is based in Galway, Ireland. The company is the applicant of record for the device's FDA 510(k) clearance.
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: Neurent Medical | NEUROMARK for Chronic Rhinitis, About Neurent Medical | Discover NEUROMARK for Chronic Rhinitis, NEUROMARK System NMK00301 The NEUROMARK System is… - FDA.report, Neuromark Treatment Benefits Allergic and Nonallergic Rhinitis Patients ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222032 | Class II | Active |
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Manufacturer
- Manufacturer
- Neurent Medical
Sources (1)
- FDA 510(k) K222032 24 fields · synced Sep 26, 2026