510(k) K262315
K262315 is an FDA 510(k) premarket notification submitted by Monteris Medical for the device "NeuroBlate System". The FDA issued a decision of Substantially Equivalent on September 3, 2026. The device falls under product code ONO (Neurosurgical Laser With Mr Thermography), a Class II device regulated under 21 CFR 878.4810. Monteris Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 3, 2026
- Date Received
- July 8, 2026
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Neurosurgical Laser With Mr Thermography
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- NE
- Submission Type
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.