K240877 is an FDA 510(k) clearance for the Monteris Medical NeuroBlate System. This device is classified as a Neurosurgical Laser With Mr Thermography (Class II - Special Controls, product code ONO).
Submitted by Monteris Medical, (Minnetonka, US). The FDA issued a Cleared decision on June 4, 2024, 67 days after receiving the submission on March 29, 2024.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 878.4810. 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..
| 510(k) Number | K240877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2024 |
| Decision Date | June 04, 2024 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | ONO - Neurosurgical Laser With Mr Thermography |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | 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. |