510(k) K250636 ยท JXG Shunt, Central Nervous System And Components
Sophy Mini Monopressure Valve (SM1)
| Applicant | Sophysa, Orsay, FR |
| Decision | Substantially Equivalent, Nov 28, 2025 |
| Received | Mar 3, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250636
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.