Data / Medical devices / France / Sophysa

Sophysa: FDA-registered device maker in BESANCON Doubs, France, 14 510(k) clearances

Name: Sophysa FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sophysa is registered with the FDA (registration 3006240422) in BESANCON Doubs, France. It lists 4 device types. The FDA files 14 510(k) clearances under its listings, the newest dated November 28, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006240422
FEI number: 3001587388
Address: Rue Sophie Germain Technopole TEMIS, BESANCON Doubs, France, 25000
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

Compare with other makers

Updated November 28, 2025. 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.