Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001587388

FEI Number

3001587388

Entity Name

SOPHYSA

City/State/Country

ORSAY, CEDEX Essonne, FR

Establishment Address

05 RUE GUY MOQUET, ORSAY, CEDEX Essonne 91400, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SOPHYSA (Owner Number: 10023919)

Owner / Operator Contact Address

5 RUE GUY MOQUET, ORSAY, FR-91 91400, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K091328

PMA Number

N/A

All Registered Proprietary Names

Pressio 2 ICP monitoring system SOPHY PRESSIO POLARIS Adjustable Pressure Valve System POLARIS Adjustable Pressure Valve SOPHYSA SHUNT SOPHYSA SHUNT SOPHYSA SHUNT SOPHYSA ACCESSORIES POLARIS Valves electronic Reading Instrument Siphon X Gravitational Anti-siphon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2017-07-24
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2007-12-21
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2007-12-21
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2020-11-25
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2010-05-25
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2010-05-25
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2010-05-25
GYK	Instrument, Shunt System Implantation	Neurology	Class 1	882.4545	2010-05-25
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2023-04-04
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2010-02-01

Official Correspondent

Philippe NEGRE

US Agent Details

Paul GORDON Business: SOPHYSA USA Inc Email: Paul.Gordon@sophysa.us Phone: (219) 6637711

Related Public Records

Same Entity

SOPHYSA

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006240422	SOPHYSA	BESANCON Doubs, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21
K981246	Integra Neurocare, LLC	BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)	1999-05-26

Similar Registrations

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3004593495	Plexus Manufacturing Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
3014334038	Integra LifeSciences Production Corporation	Mansfield, MA, US
3013944123	Eurofins Infinity Laboratory Group Inc.	San Jose, CA, US
3013886523	Integra LifeSciences Switzerland Sarl	Le Locle Neuchatel, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001587388. Last updated year: 2026. Please use registration number 3001587388 when referencing this establishment in official correspondence.