JXG · Class II · 21 CFR 882.5550

FDA Product Code JXG: Shunt, Central Nervous System And Components

Hydrocephalus is managed with shunt systems that divert excess cerebrospinal fluid. FDA product code JXG covers central nervous system shunts and their components.

These implanted systems typically consist of a ventricular catheter, a valve mechanism, and a distal catheter that diverts excess cerebrospinal fluid from the ventricles to the peritoneal cavity, pleura, or atrium. Programmable valves allow non-invasive adjustment of drainage pressure.

JXG devices are Class II medical devices, regulated under 21 CFR 882.5550 and reviewed by the FDA Neurology panel.

Leading manufacturers include Codman & Shurtleff, Inc., Holter-Hausner Intl. and Pudenz-Schulte Medical Research Corp..

259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
49–72 of 259
Cleared Oct 27, 2015
Codman Certas Plus Programmable Valve
K152152
Medos International SARL
Neurology · 85d
Cleared Apr 02, 2015
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
K141227
Sophysa SA
Neurology · 325d
Cleared Apr 02, 2015
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
K141687
Aesculap, Inc.
Neurology · 294d
Cleared Feb 19, 2015
Codman Certas Plus Programmable Valve
K143111
Medos International SARL
Neurology · 113d
Cleared Jan 06, 2015
INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS
K140722
Integra LifeSciences Corporation
Neurology · 291d
Cleared Dec 13, 2013
LIQUOGUARD CSF LIQUOGUARD CSF TUBING SET (1500MM) LIQUOGUARD CSF TUBING SET (2000MM) SAFETY CUSHION FOR TUBING SET ATTAC
K121248
Moller Medical GmbH
Neurology · 597d
Cleared Mar 07, 2013
SHUNTCHECK
K123554
Neurodx Development, LLC
Neurology · 108d
Cleared Feb 13, 2013
MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K123524
Medtronic Neurosurgery
Neurology · 90d
Cleared Aug 03, 2012
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
K122118
Codman & Shurtleff, Inc.
Neurology · 17d
Cleared May 24, 2012
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
K120559
Aesculap, Inc.
Neurology · 90d
Cleared Feb 16, 2012
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
K113526
Medos International SARL
Neurology · 78d
Cleared Nov 18, 2011
MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER
K110560
Medtronic Neurosurgery
Neurology · 263d
Cleared Oct 27, 2011
AESCULAP- MEITHKE SHUNT SYSTEM
K110206
Aesculap, Inc.
Neurology · 275d
Cleared Oct 17, 2011
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM
K112156
Medos International SARL
Neurology · 82d
Cleared Jul 07, 2011
HORIZONTAL-VERTICAL LUMBAR VALVE AND SPETZLER LUMBAR PERITONEAL SHUNT SYSTEMS
K101381
Integra LifeSciences Corporation
Neurology · 416d
Cleared May 09, 2011
CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER
K110751
Codman & Shurtleff, Inc.
Neurology · 52d
Cleared Feb 18, 2011
HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS
K102961
Codman & Shurtleff, Inc.
Neurology · 136d
Cleared Jan 14, 2011
CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER
K102589
Codman & Shurtleff, Inc.
Neurology · 127d
Cleared Nov 09, 2010
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
K103003
Aesculap, Inc.
Neurology · 28d
Cleared Jan 22, 2010
OSV II LOW FLOW LOW PRO VALVE
K093968
Integra LifeSciences Corporation
Neurology · 30d
Cleared Nov 19, 2009
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM
K092395
Integra Lifesciences Corp.
Neurology · 106d
Cleared Sep 02, 2009
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM
K091312
Medtronic Neurosurgery
Neurology · 121d
Cleared Jun 02, 2009
CODMAN HAKIM MICRO II VALVE
K091346
Codman & Shurtleff, Inc.
Neurology · 26d
Cleared Mar 04, 2009
CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET
K090348
Codman & Shurtleff, Inc.
Neurology · 21d