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 21, 2019
M. Blue Adjustable Shunt System
Aesculap, Inc.
Neurology
92d
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
Nov 14, 2017
Smart External Drain (SED) System
Aqueduct Critical Care, Inc.
Neurology
62d
Cleared
Nov 09, 2017
Alivio Ventricular Catheter and Flusher System (Alivio System)
Alcyone Lifesciences, Inc.
Neurology
129d
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
Aug 31, 2017
SureFlo EVD Catheter
Arkis Biosciences, Inc.
Neurology
183d
Cleared
Jun 30, 2017
Smart External Drain (SED) System
Aqueduct Critical Care, Inc.
Neurology
30d
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
Oct 27, 2016
Smart External Drain (SED) System
Aqueduct Critical Care, Inc.
Neurology
139d
Cleared
Sep 22, 2016
Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt Systems
Integra LifeSciences Corporation
Neurology
65d
Cleared
Apr 07, 2016
StrataMR Valves and Shunts
Medtronic Neurosurgery
Neurology
199d
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
Dec 18, 2015
LiquoGuard 7, LiquoGuard 7 Drainage Set, Lenght 2000mm
Moller Medical GmbH
Neurology
260d