NeuroBlate System
FDA 510(k) K262315 · Monteris Medical
510(k) numberK262315
Submission
- Device name
- NeuroBlate System
- Applicant
- Monteris Medical
Minnetonka, MN, US - Received
- July 8, 2026
- Decision date
- September 3, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ONO – Neurosurgical Laser With Mr Thermography
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
Laser device for use to necrotize or coagulate soft tissue through interstitial irradition or thermal therapy under mri guidance and real time mr thermography in neurosurgery.
Other 510(k)s with product code ONO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260976 | NeuroBlate SystemONO · Special | Monteris Medical | 04/23/2026SE |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…ONO · Traditional | Medtronic Navigation, Inc. | 03/13/2026SE |
| K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator…ONO · Traditional | Clinical Laserthermia Systems, AB | 09/04/2025SE |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422)ONO · Traditional | Medtronic Navigation | 05/29/2025SE |
| K240877 | Monteris Medical NeuroBlate SystemONO · Traditional | Monteris Medical, | 06/04/2024SE |
| K214125 | TRANBERG Thermoguide Therapy SystemONO · Traditional | Clinical Laserthermia Systems, AB | 09/22/2022SE |
| K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4)ONO · Traditional | Medtronic Navigation, Inc. | 01/07/2022SE |
More from Medtronic Navigation, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260976 | NeuroBlate SystemONO · Special | 04/23/2026SE |
| K240877 | Monteris Medical NeuroBlate SystemONO · Traditional | 06/04/2024SE |
| K231061 | NeuroBlate SystemGEX · Traditional | 12/08/2023SE |
| K222983 | NeuroBlate Fusion-S Software V3.17GEX · Traditional | 03/15/2023SE |
| K201056 | NeuroBlate SystemGEX · Traditional | 08/21/2020SE |
| K193375 | NeuroBlate SystemGEX · Special | 01/03/2020SE |
| K182036 | NeuroBlate SystemGEX · Traditional | 10/15/2018SE |
| K173305 | NeuroBlate SystemGEX · Special | 11/17/2017SE |
| K172881 | NeuroBlate SystemGEX · Special | 10/20/2017SE |
| K171255 | Monteris Medical NeuroBlate SystemGEX · Traditional | 07/25/2017SE |
Questions and answers
When was NeuroBlate System cleared by the FDA?
NeuroBlate System (K262315) received a 510(k) decision of Substantially Equivalent on September 3, 2026, 57 days after the submission was received.
What is the product code of K262315?
The FDA product code is ONO – Neurosurgical Laser With Mr Thermography, a Class II (moderate risk) device regulated under 21 CFR 878.4810.