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..

260
Total
260
Cleared
126d
Avg days
1976
Since
260 devices
97–120 of 260
Cleared Nov 02, 2004
SHUNTCHECK (PROMETHEUS 1)
K040021
Samuel Neff M.D.
Neurology · 301d
Cleared Oct 19, 2004
PS MEDICAL STRATA II VALVE
K042465
Medtronic Neurosurgery
Neurology · 36d
Cleared Oct 06, 2004
EQUI-FLOW VALVE AND SHUNT SYSTEM
K042558
Integra Neurosciences Implants S.A.
Neurology · 15d
Cleared Sep 24, 2004
PS MEDICAL NEUROSURGICAL IMPLANTS
K042198
Medtronic Neurosurgery
Neurology · 42d
Cleared Sep 02, 2004
LOW FLOW OSV II HYDROCEPHALUS VALVE
K042192
Integra Neurosciences Implants S.A.
Neurology · 21d
Cleared Jun 15, 2004
MEDTRONIC PS MEDICAL STRATA VALVE
K040943
Medtronic Neurosurgery
Neurology · 64d
Cleared Jun 10, 2004
MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI
K041296
Codman & Shurtleff, Inc.
Neurology · 27d
Cleared May 27, 2004
MODIFICATION TO LUMBO-PERITONEAL SHUNTS AND LUMBAR DRAINAGE CATHETERS
K033704
Vygon Us, LLC
Neurology · 184d
Cleared Apr 07, 2004
PHOENIX INFUSION CATHETER
K033017
Phoenix Biomedical
Neurology · 194d
Cleared Feb 26, 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
K031097
Sophysa SA
Neurology · 325d
Cleared Feb 26, 2004
MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM
K040201
Integra Neurosciences Implants S.A.
Neurology · 28d
Cleared Jan 13, 2004
MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE
K033850
Medtronic Neurosurgery
Neurology · 33d
Cleared Dec 17, 2003
CONTOUR-FLEX VALVE AND SHUNT SYSTEM
K033698
Integra Neurosciences Implants S.A.
Neurology · 22d
Cleared Oct 15, 2003
ACURA ELITE GRAVITY COMPENSATING RESERVOIR
K030468
Phoenix Biomedical Corp.
Neurology · 245d
Cleared Oct 06, 2003
CSF400 AND CSF600
K030081
Inmed Ltda.
Neurology · 270d
Cleared Oct 06, 2003
EXTERNAL DRAINAGE SET
K032817
Integra Neurosciences Implants S.A.
Neurology · 26d
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 Jan 27, 2003
ACCURA ELITE SHUNT SYSTEM
K024040
Phoenix Biomedical Corp.
Neurology · 52d
Cleared Jan 27, 2003
PHOENIX UNIVERSAL SHUNT SYSTEM
K024101
Phoenix Biomedical Corp.
Neurology · 46d
Cleared Aug 23, 2002
MONITORR ICP EXTERNAL CSF DRAINAGE AND MONITORING SYSTEM
K022554
Integra Neurosciences
Neurology · 21d
Cleared Aug 06, 2002
PERF (OMMAYA STYLE) RESERVOIRS
K021644
Phoenix Biomedical Corp.
Neurology · 78d
Cleared Jul 29, 2002
CODMAN BACTISEAL EVD CATHETER SET
K021653
Codman & Shurtleff, Inc.
Neurology · 70d