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
25–48 of 259
Cleared Nov 15, 2019
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K192289
Irras USA, Ltd.
Neurology · 84d
Cleared Oct 11, 2019
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
K191684
Integra LifeSciences Corporation
Neurology · 109d
Cleared Jul 05, 2019
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
K190174
Aesculap, Inc.
Neurology · 154d
Cleared Nov 20, 2018
CodMan Certas Plus Programmable Valve
K182265
Integra Lifesciences Corp.
Neurology · 91d
Cleared Oct 25, 2018
Codman Certas Plus Electronic Tool Kit
K181902
Integra Lifesciences Corp.
Neurology · 101d
Cleared Oct 01, 2018
StrataMR guider tool
K181622
Medtronic Neurosurgery
Neurology · 103d
Cleared Jul 13, 2018
IRRAflow CNS System
K171880
Irras, Inc.
Neurology · 385d
Cleared Jun 14, 2018
Smart External Drain (SED) System
K181301
Aqueduct Critical Care, Inc.
Neurology · 28d
Cleared Mar 24, 2018
EKOS ultrasound EVD Device, EVD Control Unit
K172035
Btg International, Inc.
Neurology · 262d
Cleared Oct 16, 2017
Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag
K172537
Codman & Shurtleff, Inc.
Neurology · 55d
Cleared Oct 03, 2017
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
K172022
Codman & Shurtleff, Inc.
Neurology · 90d
Cleared Feb 27, 2017
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
K161853
Aesculap, Inc.
Neurology · 236d
Cleared Oct 28, 2016
Codman EDS3 CSF External Drainage System
K162437
Codman & Shurtleff, Inc.
Neurology · 58d
Cleared Sep 22, 2016
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
K161992
Integra LifeSciences Corporation
Neurology · 65d
Cleared Mar 14, 2016
Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
K153041
Integra LifeSciences Corporation
Neurology · 147d
Cleared Mar 04, 2016
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
K152897
Integra LifeSciences Corporation
Neurology · 155d
Cleared Oct 27, 2015
Codman Certas Plus Programmable Valve
K152152
Medos International SARL
Neurology · 85d
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 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 Oct 27, 2011
AESCULAP- MEITHKE SHUNT SYSTEM
K110206
Aesculap, Inc.
Neurology · 275d