510(k) clearance
cCeLL - In vivo
- 510(k) number
- K260315
- Applicant
- VPIX Medical, Inc.
- Decision date
- Oct 16, 2026
- Date received
- Jan 30, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GWG
- Device type
- Endoscope, Neurological
- Device class
- Class II
- Regulation
- 21 CFR 882.1480
- Advisory committee
- Neurology
- Statement or summary
- Summary
- Third party
- N
- Location
- Daejeon, KR