Sophysa
ORSAY, CEDEX Essonne, FR
SOPHYSA appears in FDA device records in ORSAY, CEDEX Essonne, FR. FDA records list 13 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for Sophysa between 2000 and 2026. The busiest year on record is 2004, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2002 | 1 |
| 2004 | 2 |
| 2007 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2015 | 1 |
| 2017 | 1 |
| 2023 | 1 |
| 2025 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252241 | Pressio 3 Multi-parameter Neuromonitoring System | GWM | Substantially Equivalent | |
| K250636 | Sophy Mini Monopressure Valve (SM1) | JXG | Substantially Equivalent | |
| K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | JXG | Substantially Equivalent | |
| K222422 | Polaris Valve Electronic Reading Instrument | JXG | Substantially Equivalent | |
| K162108 | Pressio 2 ICP Monitoring System | GWM | Substantially Equivalent | |
| K141227 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX | JXG | Substantially Equivalent | |
| K091328 | SIPHONX GRAVITATIONAL ANTISIPHON DEVICE | JXG | Substantially Equivalent | |
| K090342 | POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300, SPV-400 | JXG | Substantially Equivalent | |
| K062584 | PRESSIO ICP MONITORING SYSTEM | GWM | Substantially Equivalent | |
| K042481 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 | JXG | Substantially Equivalent | |
| K031097 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB | JXG | Substantially Equivalent | |
| K013488 | SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 | JXG | Substantially Equivalent | |
| K992465 | SOPHY SU8 PRESSURE ADJUSTABLE VALVE | JXG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3001587388 | 3001587388 | SOPHYSA | 05 RUE GUY MOQUET, ORSAY, CEDEX Essonne 91400 FR | 2026 | |
| 3006240422 | 3001587388 | SOPHYSA | Rue Sophie Germain, BESANCON Doubs 25000 FR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1029-2026 | The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor | Customer complaints of Pressio monitor rebooting. | Class II | Open, Classified | |
| Z-1826-2024 | 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 in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VTT | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion. | Class II | Open, Classified | |
| Z-1825-2024 | The Sophysa Pressio Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. Model/Catalog Number: PSO-VT | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error involving perforation of the inner channel of the catheter during stylet insertion. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain