510(k) K162108 ยท GWM Device, Monitoring, Intracranial Pressure
Pressio 2 ICP Monitoring System
| Applicant | Sophysa SA, Orsay, FR |
| Decision | Substantially Equivalent, Apr 17, 2017 |
| Received | Jul 29, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162108
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2026 | Sophysa The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor Open, Classified |
GWM | None listed |
| May 15, 2024 | Sophysa S.A. The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricul Open, Classified |
GWM | None listed |
| May 15, 2024 | Sophysa S.A. The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use Open, Classified |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.