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
Cleared
Nov 15, 2019
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
Irras USA, Ltd.
Neurology
84d
Cleared
Oct 11, 2019
MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System
Integra LifeSciences Corporation
Neurology
109d
Cleared
Jul 05, 2019
Miethke Shunt System GAV 2.0 and SA 2.0 Valves
Aesculap, Inc.
Neurology
154d
Cleared
Nov 20, 2018
CodMan Certas Plus Programmable Valve
Integra Lifesciences Corp.
Neurology
91d
Cleared
Oct 25, 2018
Codman Certas Plus Electronic Tool Kit
Integra Lifesciences Corp.
Neurology
101d
Cleared
Oct 01, 2018
StrataMR guider tool
Medtronic Neurosurgery
Neurology
103d
Cleared
Jul 13, 2018
IRRAflow CNS System
Irras, Inc.
Neurology
385d
Cleared
Jun 14, 2018
Smart External Drain (SED) System
Aqueduct Critical Care, Inc.
Neurology
28d
Cleared
Mar 24, 2018
EKOS ultrasound EVD Device, EVD Control Unit
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
Codman & Shurtleff, Inc.
Neurology
55d
Cleared
Oct 03, 2017
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
Codman & Shurtleff, Inc.
Neurology
90d
Cleared
Feb 27, 2017
proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System
Aesculap, Inc.
Neurology
236d
Cleared
Oct 28, 2016
Codman EDS3 CSF External Drainage System
Codman & Shurtleff, Inc.
Neurology
58d
Cleared
Sep 22, 2016
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
Integra LifeSciences Corporation
Neurology
65d
Cleared
Mar 14, 2016
Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling
Integra LifeSciences Corporation
Neurology
147d
Cleared
Mar 04, 2016
Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory
Integra LifeSciences Corporation
Neurology
155d
Cleared
Oct 27, 2015
Codman Certas Plus Programmable Valve
Medos International SARL
Neurology
85d
Cleared
Apr 02, 2015
AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM
Aesculap, Inc.
Neurology
294d
Cleared
Feb 19, 2015
Codman Certas Plus Programmable Valve
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
Integra LifeSciences Corporation
Neurology
291d
Cleared
Aug 03, 2012
HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM
Codman & Shurtleff, Inc.
Neurology
17d
Cleared
May 24, 2012
AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM
Aesculap, Inc.
Neurology
90d
Cleared
Feb 16, 2012
CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM
Medos International SARL
Neurology
78d
Cleared
Oct 27, 2011
AESCULAP- MEITHKE SHUNT SYSTEM
Aesculap, Inc.
Neurology
275d