# K222983: NeuroBlate Fusion-S Software V3.17

- Pathway: 510(k) (Traditional)
- Applicant: Monteris Medical,
- Decided: Mar 15, 2023 after 168 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 17 generations back to K983831 (1999). 35 ancestors in all.
7 later devices descend from it; 1 cites it directly.
2 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193375: NeuroBlate System, Monteris Medical, (2020) Summary page 4.
- K201056: NeuroBlate System, Monteris Medical, Inc. (2020) Summary page 4.

## Most influential descendants
- K231061: NeuroBlate System (2023), 6 descendants of its own
- K240877: Monteris Medical NeuroBlate System (2024), 5 descendants of its own
- K260976: NeuroBlate System (2026), 1 descendant of its own
- K250307: Visualase V2 MRI-guided Laser Ablation System (9736422) (2025), 1 descendant of its own
- K262315: NeuroBlate System (2026), 0 descendants of its own

## 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 (e.g., brain tumor, radiation necrosis, and epileptogenic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging), through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate Laser Delivery Probes. It also provides near real-time thermographic analysis of selected MRI images. When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate System analysis.

Source page: https://510kreport.com/device/K222983
Methodology: https://510kreport.com/methodology