Data / Medical devices / France / Sophysa
Sophysa: FDA-registered device maker in ORSAY, CEDEX Essonne, France, 14 510(k) clearances
Sophysa is registered with the FDA (registration 3001587388) in ORSAY, CEDEX Essonne, France. It lists 4 device types. The FDA files 14 510(k) clearances under its listings, the newest dated November 28, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3001587388
- Address
- 05 Rue Guy Moquet, ORSAY, CEDEX Essonne, France, 91400
- Owner or operator
- SOPHYSA (10023919)
- Roles
- Manufacturer
- First device listed
- December 21, 2007
- Registered through
- 2026
- Brand names listed
- External Drainage catheters, POLARIS Adjustable Pressure Valve, POLARIS Adjustable Pressure Valve System, POLARIS Valves electronic Reading Instrument, PRESSIO, Pressio 2 ICP monitoring system, SOPHY, SOPHYSA ACCESSORIES and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Monitoring, Intracranial Pressure | GWM | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Shunt System Implantation | GYK | 1 | Manufacturer | accessdata.fda.gov |
| Lumbar Drainage Catheter Kit | PVO | 2 | Manufacturer | accessdata.fda.gov |
| Shunt, Central Nervous System And Components | JXG | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 28, 2025 | K250636 | Sophy Mini Monopressure Valve (SM1) | JXG | Substantially Equivalent | Sophysa | accessdata.fda.gov |
| June 20, 2025 | K242974 | External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters | JXG | Substantially Equivalent | Sophysa | accessdata.fda.gov |
| February 2, 2023 | K222422 | Polaris Valve Electronic Reading Instrument | JXG | Substantially Equivalent | Sophysa | accessdata.fda.gov |
| April 17, 2017 | K162108 | Pressio 2 ICP Monitoring System | GWM | Substantially Equivalent | Sophysa SA | accessdata.fda.gov |
| April 2, 2015 | K141227 | POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX | JXG | Substantially Equivalent | Sophysa SA | accessdata.fda.gov |
| January 22, 2010 | K091328 | SIPHONX GRAVITATIONAL ANTISIPHON DEVICE | JXG | Substantially Equivalent | Sophysa SA | accessdata.fda.gov |
| July 5, 2007 | K062584 | PRESSIO ICP MONITORING SYSTEM | GWM | Substantially Equivalent | Sophysa SA | accessdata.fda.gov |
| April 7, 2004 | K033017 | PHOENIX INFUSION CATHETER | JXG | Substantially Equivalent | Phoenix Biomedical | accessdata.fda.gov |
| March 27, 2002 | K013488 | SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8 | JXG | Substantially Equivalent | Sophysa SA | accessdata.fda.gov |
| September 18, 1985 | K853371 | H-H ATRIAL CATHETERS & PERITONEAL CATHETERS | JXG | Substantially Equivalent | Holter-Hausner Intl. | accessdata.fda.gov |
| September 18, 1985 | K853370 | H-H CATHETER PASSERS(TACL DESIGN | GYK | Substantially Equivalent | Holter-Hausner Intl. | accessdata.fda.gov |
| September 11, 1985 | K853369 | H-H FIXATION & JOINING CONNECTORS | JXG | Substantially Equivalent | Holter-Hausner Intl. | accessdata.fda.gov |
| September 5, 1985 | K853365 | H-H FIFTH VENTRICLE | JXG | Substantially Equivalent | Holter-Hausner Intl. | accessdata.fda.gov |
| September 3, 1985 | K853362 | H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER | JXG | Substantially Equivalent | Holter-Hausner Intl. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| November 17, 2025 | 98073 | Class II | Ongoing | The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor | Customer complaints of Pressio monitor rebooting. | accessdata.fda.gov |
| April 9, 2024 | 94464 | Class II | Ongoing | 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 monitori | 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 insert | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Shunt System Implantation
- All makers of Shunt, Central Nervous System And Components
- All makers of Device, Monitoring, Intracranial Pressure
- All makers of Lumbar Drainage Catheter Kit
Updated January 8, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.