FDA.reportPublic FDA data

Paul GORDON

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30062404223001587388Paul GORDON1N2026-01-01503 E Summit St Suite 5 Crown Point IN US 46307

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1046771577105152K853371H-H ATRIAL CATHETERS & PERITONEAL CATHETERSJXG1985-09-18
1046771027325067K853370H-H CATHETER PASSERS(TACL DESIGNGYK1985-09-18
1046771196732712K853369H-H FIXATION & JOINING CONNECTORSJXG1985-09-11
1046771548866216K853365H-H FIFTH VENTRICLEJXG1985-09-05
1046771550461045K853362H-H SLOTTED VENTRICULAR CATHETER/SLOTTED CATHETERJXG1985-09-03
1046771254514749K250636Sophy Mini Monopressure Valve (SM1)JXG2025-11-28
1046771776977406K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersJXG2025-06-20
1046771682439680K222422Polaris Valve Electronic Reading InstrumentJXG2023-02-02
1046771886333334K162108Pressio 2 ICP Monitoring SystemGWM2017-04-17
1046771263098347K141227POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONXJXG2015-04-02
1046771317875494K091328SIPHONX GRAVITATIONAL ANTISIPHON DEVICEJXG2010-01-22
1046771036745384K062584PRESSIO ICP MONITORING SYSTEMGWM2007-07-05
1046771779188838K033017PHOENIX INFUSION CATHETERJXG2004-04-07
1046771907790471K013488SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8JXG2002-03-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JXG112025-11-28
GWM22017-04-17
GYK11985-09-18