Medical Device Manufacturer · US , Wellesley , MA

Sophysa SA - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2000

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sophysa SA Neurology ✕

9 devices

1-9 of 9

Cleared Apr 17, 2017

Pressio 2 ICP Monitoring System

Neurology · 262d

Cleared Apr 02, 2015

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX

Neurology · 325d

Cleared Jan 22, 2010

SIPHONX GRAVITATIONAL ANTISIPHON DEVICE

Neurology · 262d

Cleared Aug 11, 2009

POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300,...

Neurology · 182d

Cleared Jul 05, 2007

PRESSIO ICP MONITORING SYSTEM

Neurology · 307d

Cleared Dec 14, 2004

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400

Neurology · 92d

Cleared Feb 26, 2004

POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB

Neurology · 325d

Cleared Mar 27, 2002

SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8

Neurology · 159d

Cleared Sep 21, 2000

SOPHY SU8 PRESSURE ADJUSTABLE VALVE

Neurology · 426d