Company ยท US
Sophysa SA
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2026. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (2 in 12 months)
3recalls (1 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 10, 2026 | K252241 | Pressio 3 Multi-parameter Neuromonitoring System Sophysa, FR | GWM |
| Nov 28, 2025 | K250636 | Sophy Mini Monopressure Valve (SM1) Sophysa, FR | JXG |
| Jun 20, 2025 | K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters Sophysa, FR | JXG |
| Feb 2, 2023 | K222422 | Polaris Valve Electronic Reading Instrument Sophysa, FR | JXG |
| Apr 17, 2017 | K162108 | Pressio 2 ICP Monitoring System Sophysa SA, FR | GWM |
| Apr 2, 2015 | K141227 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX Sophysa SA | JXG |
| Jan 22, 2010 | K091328 | SIPHONX GRAVITATIONAL ANTISIPHON DEVICE Sophysa SA | JXG |
| Aug 11, 2009 | K090342 | POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 Sophysa SA | JXG |
| Jul 5, 2007 | K062584 | PRESSIO ICP MONITORING SYSTEM Sophysa SA | GWM |
| Dec 14, 2004 | K042481 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 Sophysa SA | JXG |
| Feb 26, 2004 | K031097 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB Sophysa SA | JXG |
| Mar 27, 2002 | K013488 | SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 Sophysa SA | JXG |
| Sep 21, 2000 | K992465 | SOPHY SU8 PRESSURE ADJUSTABLE VALVE Sophysa SA | JXG |
Latest recalls
| 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 | K162108 |
| 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 | K062584 K162108 |
| 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 | K062584 K162108 |