510(k) K211346
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2022
- Date Received
- May 3, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diagnostic Neurosurgical Microscope Filter
- Device Class
- Class II
- Regulation Number
- 882.4950
- Review Panel
- NE
- Submission Type
A diagnostic neurosurgical microscope filter is a device intended for use during neurosurgery to visualize fluorescence and enhance visualization of tissue associated with a specific disease or condition.