Sophysa is one of 174 FDA 510(k) medical device manufacturers from France in the dataset, ranked by real submission volume.
Sophysa - FDA 510(k) Cleared Devices
Recent clearances: Pressio 3 Multi-parameter Neuromonitoring System, Sophy Mini Monopressure Valve (SM1), External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
4
Total
4
Cleared
0
Denied
Sophysa has 4 FDA 510(k) cleared medical devices. Based in Orsay, FR.
Latest FDA clearance: Apr 2026. Active since 2023. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Sophysa Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Sophysa
4 devices
Cleared
Apr 10, 2026
Pressio 3 Multi-parameter Neuromonitoring System
Neurology
267d
Cleared
Nov 28, 2025
Sophy Mini Monopressure Valve (SM1)
Neurology
270d
Cleared
Jun 20, 2025
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar...
Neurology
267d
Cleared
Feb 02, 2023
Polaris Valve Electronic Reading Instrument
Neurology
175d