K260976
- 510(k) number
- K260976
- Device name
- NeuroBlate System
- Applicant
- Monteris Medical MN · US
- Product code
- ONO — Neurosurgical Laser With Mr Thermography
- Decision date
- 2026-04-23
- Date received
- 2026-03-24
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K260976.pdf
Official FDA record: K260976
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.