SOPHYSA

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2087487	3005193143	SOPHYSA USA INC	1	Y	2026-01-01	503 E Summit Street Suite 5 Crown Point IN US 46307
3001587388	3001587388	SOPHYSA	1	N	2026-01-01	05 RUE GUY MOQUET ORSAY, CEDEX Essonne FR 91400

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
79600	1549894540	K991429	DIAMOND II VALVE	JXG	1999-05-19
79600	1276163345	K990256	CRX WORLD SHUNT	JXG	1999-04-01
79600	1834956340	K974096	CRX DIAMOND VALVE	JXG	1998-12-08
79600	1404218047	K960435	PHOENIX CRX VALVE	JXG	1996-08-27
79600	1531686663	K913490	PHOENIX BURR HOLE BUTTON, BURR 1	GXR	1992-01-13
79600	1638079999	K895524	HYDROCEPHALUS SHUNT SYSTEM, LOW/MEDIUM/HIGH PRESS.	JXG	1990-04-10
79600	1143469551	K875287	H-H FLUSHING RESERVOIR	JXG	1988-07-14
79600	2065239805	K874508	H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG	JXG	1988-01-19
79600	1195159143	K870660	H-H EXTERNAL VENTRICULAR DRAIN (EVD) COMP./SYSTEMS	JXG	1987-05-01
79600	1460891909	K865075	H-H SUBGALEAL TROCAR	GYK	1987-01-13
79600	1577105152	K853371	H-H ATRIAL CATHETERS & PERITONEAL CATHETERS	JXG	1985-09-18
79600	1027325067	K853370	H-H CATHETER PASSERS(TACL DESIGN	GYK	1985-09-18
79600	1196732712	K853369	H-H FIXATION & JOINING CONNECTORS	JXG	1985-09-11
79600	1541554148	K853368	H-H SHUNT INTRODUCER	GYK	1985-09-06
79600	1038092561	K853367	H-H BURR HOLE CATHETER SUPPORT	GXR	1985-09-11
79600	1917217381	K853366	H-H UNITIZED STANDARD SHUNT/RESERVOIR SHUNT	JXG	1985-09-11
79600	1548866216	K853365	H-H FIFTH VENTRICLE	JXG	1985-09-05
79600	1597400215	K853364	H-H RICKHAM TYPE RESERVOIR	JXG	1985-09-05
79600	1779029702	K853363	H-H CRUCIFORM-SLIT VALVE	JXG	1985-09-03
79600	1550461045	K853362	H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETER	JXG	1985-09-03
79600	1794814997	K853361	H-H VENTRICULAR CATHETERS & RESERVOIRS	JXG	1985-08-28
79600	1598220394	K841553	H-H SHUNT PASSERS	GYK	1984-05-14
79600	1812182245	K830894	H-H IN-LINE VALVED CATHETER 2 TYPES	JXG	1983-04-08
79600	1018947276	K822048	H-H NERVE ROOT RETRACTOR	HAO	1982-07-22
79600	1867654978	K820312	H-H RICKHAM TYPE RESERVOIR	JXG	1982-03-01
79600	1636901669	K820311	H-H BURR HOLE CATHETER SUPPORT	JXG	1982-02-24
79600	1083049951	K813374	NUTRICATH	FOZ	1982-03-15
79600	1362047356	K800168	H-H FIFTH VENTRICLE	JXG	1980-01-31
79600	1125505607	K792639	H-H SHUNT INTRODUCER	GYK	1979-12-31
79600	1406820035	K791076	H-H SLOTTED VENTRICULAR CATHETER	JXG	1979-08-03
79600	1496442137	K791075	H-H SLOTTED CATHETER-RESERVOIR	JXG	1979-08-03
79600	1550505117	K790849	H-H FIXATION AND JOINING CONNECTORS	JXG	1979-05-11
79600	1610372475	K790126	VALVE, H-H CRUCIFORM SLIT	JXG	1979-01-26
79600	1088123094	K782105	CATHETERS, H-H VENTRICULAR	JXG	1979-01-15
79600	1452090403	K781768	CATHETERS, H-H ATRIAL AND PERITONEAL	JXG	1978-11-14
79600	1254514749	K250636	Sophy Mini Monopressure Valve (SM1)	JXG	2025-11-28
79600	1776977406	K242974	External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters	JXG	2025-06-20
79600	1682439680	K222422	Polaris Valve Electronic Reading Instrument	JXG	2023-02-02
79600	1886333334	K162108	Pressio 2 ICP Monitoring System	GWM	2017-04-17
79600	1263098347	K141227	POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX	JXG	2015-04-02
79600	1317875494	K091328	SIPHONX GRAVITATIONAL ANTISIPHON DEVICE	JXG	2010-01-22
79600	1381023852	K081942	NEUROCATH AG	JXG	2008-08-12
79600	1036745384	K062584	PRESSIO ICP MONITORING SYSTEM	GWM	2007-07-05
79600	1376016608	K042481	POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400	JXG	2004-12-14
79600	1935595524	K033704	MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS	JXG	2004-05-27
79600	1779188838	K033017	PHOENIX INFUSION CATHETER	JXG	2004-04-07
79600	1692284933	K031097	POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB	JXG	2004-02-26
79600	1521133036	K030468	ACURA ELITE GRAVITY COMPENSATING RESERVOIR	JXG	2003-10-15
79600	1786128645	K024101	PHOENIX UNIVERSAL SHUNT SYSTEM	JXG	2003-01-27
79600	1163952782	K024040	ACCURA ELITE SHUNT SYSTEM	JXG	2003-01-27
79600	1743855788	K021644	PERF (OMMAYA STYLE) RESERVOIRS	JXG	2002-08-06
79600	1907790471	K013488	SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8	JXG	2002-03-27
79600	1111013452	K002476	LUMBOPERITONEAL SHUNT SYSTEM	JXG	2000-11-09
79600	1098036923	K000514	RUMBAR DRAINAGE SYSTEM	JXG	2000-05-10