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Sophysa S.A.

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
12
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1029-2026Class IIThe Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure MonitorNovember 17, 2025
Z-1825-2024Class IIThe Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monApril 9, 2024
Z-1826-2024Class IIThe Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monApril 9, 2024

Recent 510(k) Clearances

K-NumberDeviceDate
K250636Sophy Mini Monopressure Valve (SM1)November 28, 2025
K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJune 20, 2025
K222422Polaris Valve Electronic Reading InstrumentFebruary 2, 2023
K162108Pressio 2 ICP Monitoring SystemApril 17, 2017
K141227POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONXApril 2, 2015
K091328SIPHONX GRAVITATIONAL ANTISIPHON DEVICEJanuary 22, 2010
K090342POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400August 11, 2009
K062584PRESSIO ICP MONITORING SYSTEMJuly 5, 2007
K042481POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400December 14, 2004
K031097POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVBFebruary 26, 2004
K013488SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8March 27, 2002
K992465SOPHY SU8 PRESSURE ADJUSTABLE VALVESeptember 21, 2000