NEUROMARK System (NMK00301)
Neurent Medical , Ltd.
NEURENT MEDICAL LIMITED
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3016813690 | 3016813690 | NEURENT MEDICAL LIMITED | 1 | N | 2026-01-01 | Neurent Medical, No. 1 Oranpoint Oranmore Galway IE H91 D7X2 |
| 3021559103 | 3021559103 | NEURENT MEDICAL INC. | 1 | Y | 2026-01-01 | 150 Grossman Drive, Suite 203 Braintree MA US 02184 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 298197 | 1817766265 | K250048 | NEUROMARK System (NMK00301) | GEI | 2025-05-29 |
| 298197 | 1052967450 | K222032 | NEUROMARK System | GEI | 2022-10-26 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GEI | 2 | 2025-05-29 |
PMN#
GUDID#
NEUROMARK System - 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.
2025-06-02
NEUROMARK® Radiofrequency Console - 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.
2023-02-01
NEUROMARK® Device - 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.
2023-02-01
NEUROMARK™ Radiofrequency Generator - 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 Generator via a flexible cable. The NEUROMARK™ Radiofrequency Generator delivers, monitors and controls RF energy to the device. The generator meets the following requirements: RF operating frequency of 460 – 480 kHz (± 5 kHz); bipolar low power energy delivery and feedback control with low overshoot capabilities. The NEUROMARK™ Radiofrequency Generator is mounted on an ergonomic mobile cart for ease of use. The mobile cart includes a handle and basket. The Graphical User Interface (GUI) provides operational instructions for the procedure; directs user to select nasal cavities for treatment, indicates when the device is apposed and primed to start treatment, provides status of therapy and indicates when the procedure is complete. The NEUROMARK™ Radiofrequency Generator works in conjunction with software.
2022-04-26
NEUROMARK™ Device - 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 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 micro electrodes. These electrodes deliver bipolar radiofrequency energy while monitoring feedback on the tissue bio-impedance changes allowing for controlled radiofrequency energy level delivery. The NEUROMARK™ Device is operated via handle, slider and activation switch. The NEUROMARK Device is designed for use with the NEUROMARK Radiofrequency Generator. The NEUROMARK Device includes features to allow compatibility and authentication once connected, via a flexible cable, to the NEUROMARK Radiofrequency Generator.
2022-04-26