cCeLL405— 510(k) K254030
Substantially EquivalentVPIX Medical, Inc.
FDA 510(k) clearance K254030 for cCeLL405, Substantially Equivalent on 2026-10-02. Applicant: VPIX Medical, Inc.. Device class: 2.
Summary
cCeLL405 from VPIX Medical is filed under QFX, diagnostic neurosurgical microscope filters. The name is a model designation, and the record doesn't describe the device beyond that product code.
Class II, 21 CFR 882.4950. The Neurology panel reviewed it as a Traditional 510(k).
VPIX Medical filed from Daejeon, South Korea. The review clock ran 290 days, from December 16, 2025 to October 2, 2026. The record doesn't show how much of that was hold time.
Clearance details
- Applicant
- VPIX Medical, Inc.
- Product code
- Product code QFX
- Device class
- Class 2
- Regulation
- 21 CFR 882.4950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Daejeon, KR
Recent devices under product code QFX
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