Medical Device Manufacturer · FR , Orsay

Sophysa - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2023

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

FDA 510(k) Regulatory Record - Sophysa Neurology ✕

4 devices

1-4 of 4

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