# K261833: NEUROMARK System (NMK00301)

- Pathway: 510(k) (Special)
- Applicant: Neurent Medical, Ltd.
- Decided: Jun 16, 2026 after 14 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K000778 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250048: NEUROMARK System (NMK00301), Neurent Medical, Ltd. (2025) Summary page 5.

## Indications for use
The NEUROMARK System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions through destruction of soft tissue to disrupt posterior nasal nerves in patients with chronic rhinitis.

Source page: https://510kreport.com/device/K261833
Methodology: https://510kreport.com/methodology