# K262315: NeuroBlate System

- Pathway: 510(k) (Traditional)
- Applicant: Monteris Medical
- Decided: Sep 3, 2026 after 57 days
- Product code: ONO (Neurosurgical Laser With Mr Thermography)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K983831 (1999). 43 ancestors in all.
No later device cites it as a predicate yet.
2 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K260976: NeuroBlate System, Monteris Medical (2026) Summary page 5.
- K240877: Monteris Medical NeuroBlate System, Monteris Medical, (2024) Summary page 5.

## Indications for use
The Monteris Medical NeuroBlate System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (for example, brain tumor, radiation necrosis, and epileptogenic foci as identified by noninvasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 1064 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.

Source page: https://510kreport.com/device/K262315
Methodology: https://510kreport.com/methodology