510(k) K254030
K254030 is an FDA 510(k) premarket notification submitted by VPIX Medical, Inc. for the device "cCeLL405". The FDA issued a decision of Substantially Equivalent on Oct 2, 2026. The device falls under product code QFX (Diagnostic Neurosurgical Microscope Filter), a Class II device regulated under 21 CFR 882.4950. VPIX Medical, Inc. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 2, 2026
- Date Received
- Dec 16, 2025
- 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
- 510(k)
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.