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FDA 510(k)

NEUROMARK System (NMK00301)

K-Number: K261833 · 2026-06-16

ApplicantNeurent Medical , Ltd.
Decision Date2026-06-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NEUROMARK System (NMK00301) is the device name listed in this FDA 510(k) record. The listed applicant is Neurent Medical , Ltd.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K261833. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEUROMARK System (NMK00301)?

NEUROMARK System (NMK00301) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Neurent Medical , Ltd.. The 510(k) number is K261833.

When did NEUROMARK System (NMK00301) receive FDA 510(k) clearance?

NEUROMARK System (NMK00301) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K261833.

Who is the listed applicant for NEUROMARK System (NMK00301)?

The FDA 510(k) record lists Neurent Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEUROMARK System (NMK00301)?

The FDA product code for NEUROMARK System (NMK00301) is GEI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05324397Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis (CLARITY)COMPLETEDNCT05591989Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON)COMPLETEDNCT05937308NEUROMARK Registry StudyACTIVE_NOT_RECRUITING

Other records listing Neurent Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250048NEUROMARK System (NMK00301)K222032NEUROMARK SystemK212666Neuromark System

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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