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NEUROMARK® Device

FDA UDI

Class II (US FDA UDI)

by Neurent Medical

Identity

Trade Name
NEUROMARK® Device 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 otolaryngological [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 a hand-held, single-use, bipolar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar electrodes that deliver RF energy while monitoring feedback on tissue bio-impedance changes allowing for controlled RF energy delivery. The NEUROMARK Device is operated via handle, slider and activation button. The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency (RF) Console; it includes features to allow compatibility and authentication once connected, via a flexible interface cable, to the Console. FDA UDI
Model / Reference
FS-004-01 FDA UDI
Description
The NEUROMARK System is intended for the application of Radiofrequency (RF) energy to create lesions in mucosal tissue in otolaryngological [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 a hand-held, single-use, bipolar radiofrequency device which comprises a handle, shaft, and treatment tip. The treatment tip, which is referred to as the End Effector, consists of an array of bipolar electrodes that deliver RF energy while monitoring feedback on tissue bio-impedance changes allowing for controlled RF energy delivery. The NEUROMARK Device is operated via handle, slider and activation button. The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency (RF) Console; it includes features to allow compatibility and authentication once connected, via a flexible interface cable, to the Console. FDA UDI

Identifiers

Catalog Number
NMK-2001-05 FDA UDI
Primary DI / UDI-DI
05391537940095 FDA UDI
510(k) Number
K222032 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electrosurgical system

NEUROMARK® Device 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:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neurent Medical

Sources (1)

  • FDA UDI 71a361b3-a954-4332-b067-c6c505484460 35 fields · synced May 30, 2026