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 Medtronic Neurosurgery.

259
Total
259
Cleared
125d
Avg days
1976
Since
259 devices
97–120 of 259
Cleared Jan 13, 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
K033850
Medtronic Neurosurgery
Neurology · 33d
Cleared Jun 04, 2003
AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)
K031303
Aesculap, Inc.
Neurology · 41d
Cleared Mar 20, 2003
AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV
K030698
Aesculap, Inc.
Neurology · 14d
Cleared Feb 26, 2003
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700, NL850-830N
K030289
Integra Lifesciences Corp.
Neurology · 29d
Cleared Jul 29, 2002
CODMAN BACTISEAL EVD CATHETER SET
K021653
Codman & Shurtleff, Inc.
Neurology · 70d
Cleared Mar 28, 2002
CODMAN HAKIM SHUNT SYSTEMS
K020667
Codman & Shurtleff, Inc.
Neurology · 27d
Cleared Mar 01, 2002
AESCULAP -MIETHKE SHUNT SYSTEM
K011030
Aesculap, Inc.
Neurology · 330d
Cleared Dec 20, 2000
HAKIM PROGRAMMER AND TRANSMITTER
K003564
Codman & Shurtleff, Inc.
Neurology · 30d
Cleared Sep 21, 2000
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
K992465
Sophysa SA
Neurology · 426d
Cleared Sep 12, 2000
MEDTRONIC PS MEDICAL POLYURETHANE SHUNT, MODELS 27521, 27116, 20022
K991502
Medtronic PS Medical
Neurology · 502d
Cleared Aug 04, 2000
XDS EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K992226
Radionics, Inc.
Neurology · 399d
Cleared Apr 07, 2000
SIPHONGUARD CSF CONTROL DEVICE
K992173
Johnson & Johnson Professionals, Inc.
Neurology · 284d
Cleared Mar 20, 2000
RADIONICS LUMBOPERITONEAL SHUNT
K000057
Radionics, Inc.
Neurology · 70d
Cleared Sep 23, 1999
NMT NEUROSCIENCES CONTROL UNIT, MODEL 910-600 & NMT NEUROSCIENCES DISPOSABLE DRAINAGE LINE KIT, MODEL 910-6XX
K990660
Nmt Neurosciences Implants S.A.
Neurology · 206d
Cleared Sep 08, 1999
RADIONICS XDC EXTERNAL VENTRICULAR CATHETER
K992379
Radionics, Inc.
Neurology · 54d
Cleared May 26, 1999
BEVERLY REFERENTIAL VALVE (NL850-9710) WITH INTEGRAL PERITONEAL CATHETER (NL850-9720) VALVE KIT (NL850-9730)
K981246
Integra Neurocare, LLC
Neurology · 415d
Cleared May 19, 1999
DIAMOND II VALVE
K991429
Phoenix Biomedical Corp.
Neurology · 23d
Cleared Apr 19, 1999
RADIONICS EQUI-FLOW VALVE, VENTRICULAR AND PERITONEAL CATHETER WITH EZ-COAT
K980903
Radionics, Inc.
Neurology · 405d
Cleared Apr 01, 1999
CRX WORLD SHUNT
K990256
Phoenix Biomedical Corp.
Neurology · 64d
Cleared Mar 15, 1999
THE BIOPLATE SHUNT CONNECTOR
K984583
Biomedics
Neurology · 81d
Cleared Feb 04, 1999
BECKER EXTERNAL DRAINAGE AND MONITORING SYSTEM
K984053
Medtronic PS Medical
Neurology · 90d
Cleared Dec 08, 1998
CRX DIAMOND VALVE
K974096
Phoenix Biomedical Corp.
Neurology · 404d
Cleared Jul 17, 1998
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K980778
Johnson & Johnson Professionals, Inc.
Neurology · 137d
Cleared Jul 01, 1998
HAKIM PROGRAMMABLE VALVE SYSTEM
K974739
Johnson & Johnson Professionals, Inc.
Neurology · 194d