NEUROMARK System NMK00301

GUDID 05391537940187

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 only and is connected via a flexible interface cable.

NEURENT MEDICAL LIMITED

Electrosurgical system
Primary Device ID05391537940187
NIH Device Record Key20dd81e2-07fa-493e-aa62-b35c40445662
Commercial Distribution StatusIn Commercial Distribution
Brand NameNEUROMARK System
Version Model NumberNMK00301
Catalog NumberNMK00301
Company DUNS985640950
Company NameNEURENT MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105391537940187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-10
Device Publish Date2025-06-02

Devices Manufactured by NEURENT MEDICAL LIMITED

05391537940187 - NEUROMARK System2025-06-10The 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 only and is connected via a flexible interface cable.
05391537940187 - NEUROMARK System2025-06-10 The NEUROMARK System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolar
05391537940095 - NEUROMARK® Device2023-02-09 The NEUROMARK System is intended for the application of Radiofrequency (RF) energy to create lesions in mucosal tissue in otolar
05391537940118 - NEUROMARK® Radiofrequency Console2023-02-09 The NEUROMARK System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in otolar
05391537940002 - NEUROMARK™ Device2022-05-04 The NEUROMARK™ System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in oto
05391537940026 - NEUROMARK™ Radiofrequency Generator2022-05-04 The NEUROMARK™ System is intended for the application of radiofrequency (RF) energy to create lesions in mucosal tissue in oto
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.