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NEUROMARK® Radiofrequency Console

FDA UDI

Class II (US FDA UDI)

by Neurent Medical

Identity

Trade Name
NEUROMARK® Radiofrequency Console FDA UDI
Generic Name
Electrosurgical system FDA UDI
Device Name
The NEUROMARK System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngology [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency Console via a flexible interface cable. The NEUROMARK Console delivers, monitors and controls RF energy to the device. The Console is mounted on an ergonomic mobile stand for ease of use. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure; directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK Console works in conjunction with software. FDA UDI
Model / Reference
010-00089-000 FDA UDI
Description
The NEUROMARK System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngology [also known as Ear, Nose and Throat (ENT)] procedures in patients with chronic rhinitis. The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency Console via a flexible interface cable. The NEUROMARK Console delivers, monitors and controls RF energy to the device. The Console is mounted on an ergonomic mobile stand for ease of use. The Console includes a Graphical User Interface (GUI) which provides operational instructions for the procedure; directs the user to select nasal cavities for treatment, indicates when the device is in contact with tissue and ready to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK Console works in conjunction with software. FDA UDI

Identifiers

Primary DI / UDI-DI
05391537940118 FDA UDI
510(k) Number
K222032 FDA UDI
K250048 FDA UDI
FDA Product Code
GEI FDA UDI
GMDN Term
Electrosurgical system 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: Electrosurgical system

NEUROMARK® Radiofrequency Console by Neurent Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electrosurgical system.

Cleared under the same submission

K222032 also covers:

K250048 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurent Medical

Sources (1)

  • FDA UDI cec4243a-303e-46d1-b5ab-6a6b8c5a7edb 34 fields · synced May 30, 2026