NEUROMARK System (NMK00301)— 510(k) K261833
Substantially EquivalentNeurent Medical , Ltd.
FDA 510(k) clearance K261833 for NEUROMARK System (NMK00301), Substantially Equivalent on 2026-06-16. Applicant: Neurent Medical , Ltd.. Device class: 2.
Summary
Neurent Medical's NEUROMARK System (NMK00301) is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The record doesn't describe the system beyond the model number and the code name.
Class II, 21 CFR 878.4400. The Ear, Nose, and Throat review panel handled it as a Special 510(k), though the record lists General and Plastic Surgery as the classification panel.
Neurent filed from Galway, Ireland. Review took 14 calendar days (June 2 to June 16, 2026).
Clearance details
- Applicant
- Neurent Medical , Ltd.
- Product code
- Product code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Galway, IE
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More clearances from Neurent Medical , Ltd.
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.