K250636
- 510(k) number
- K250636
- Device name
- Sophy Mini Monopressure Valve (SM1)
- Applicant
- Sophysa FR
- Product code
- JXG — Shunt, Central Nervous System And Components
- Decision date
- 2025-11-28
- Date received
- 2025-03-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.5 MB · U.S. public domain
Also available from FDA: K250636.pdf
Official FDA record: K250636
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.