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 Cordis Corp., Integra Lifesciences Production Corporation and Aesculap, Inc..

258
Total
258
Cleared
125d
Avg days
1976
Since
Stable submission activity - 10 submissions in the last 2 years
Review times increasing: avg 195d recently vs 123d historically

FDA 510(k) Cleared Shunt, Central Nervous System And Components Devices (Product Code JXG)

258 devices
1–24 of 258
Cleared Dec 10, 2025
Intellidrop
K251598
Brainspace, Inc.
Neurology · 197d
Cleared Nov 28, 2025
Sophy Mini Monopressure Valve (SM1)
K250636
Sophysa
Neurology · 270d
Cleared Nov 05, 2025
EVAC-MRI
K252514
Phasor Health, LLC
Neurology · 86d
Cleared Aug 08, 2025
Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology
K243531
Integra Lifesciences Production Corporation
Neurology · 267d
Cleared Aug 06, 2025
Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761)
K243552
Integra Lifesciences Production Corporation
Neurology · 264d
Cleared Jun 20, 2025
External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters
K242974
Sophysa
Neurology · 267d
Cleared Jun 03, 2025
EVAC
K243205
Phasor Health, LLC
Neurology · 245d
Cleared Mar 10, 2025
Duet External Drainage and Monitoring System (EDMS)
K243676
Medtronic Neurosurgery
Neurology · 103d
Cleared Dec 16, 2024
XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
K242003
Aesculap, Inc.
Neurology · 160d
Cleared Aug 20, 2024
Borvo EVAC System (Ergo)
K241458
Borvo Medical, Inc.
Neurology · 89d
Cleared Jan 17, 2024
Bactiseal Catheters
K233445
Integra Lifesciences Production Corporation
Neurology · 90d
Cleared Dec 19, 2023
Bactiseal EVD Catheter Sets
K233448
Integra Lifesciences Production Corporation
Neurology · 60d
Cleared Oct 19, 2023
IRRAflow Active Fluid Exchange System (AFES)
K231664
Irras USA, Inc.
Neurology · 134d
Cleared Feb 09, 2023
External Drainage System
K221694
Jmed(Shenzhen) Technology Limited
Neurology · 244d
Cleared Feb 02, 2023
Polaris Valve Electronic Reading Instrument
K222422
Sophysa
Neurology · 175d
Cleared Feb 01, 2023
Certas Plus Programmable Valves
K223330
Integra Lifesciences Production Corporation
Neurology · 93d
Cleared Dec 29, 2022
Reflow System Mini and ReFlow Mini Flusher
K223603
Anuncia Medical, Inc.
Neurology · 27d
Cleared Dec 08, 2022
IRRAflow Active Fluid Exchange System (AFES)
K222471
Irras USA
Neurology · 114d
Cleared Oct 14, 2022
Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves
K221840
Integra Lifesciences Production Corporation
Neurology · 112d
Cleared Sep 29, 2022
ReFlow System Mini
K221918
Anuncia Medical, Inc.
Neurology · 90d
Cleared Sep 16, 2021
StrataMR II Valves and Shunts
K212641
Medtronic Neurosurgery
Neurology · 27d
Cleared May 08, 2020
Ventricular Catheter
K200950
Aesculap, Inc.
Neurology · 29d
Cleared Apr 29, 2020
IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit
K200807
Irras USA, Inc.
Neurology · 33d
Cleared Nov 21, 2019
M. Blue Adjustable Shunt System
K192266
Aesculap, Inc.
Neurology · 92d

About Product Code JXG - Regulatory Context

510(k) Submission Activity

258 total 510(k) submissions under product code JXG since 1976, with 258 receiving FDA clearance (average review time: 125 days).

Submission volume has remained relatively stable over the observed period, with 10 submissions in the last 24 months.

FDA 510(k) Review Time - JXG Product Code

Recent submissions under JXG have taken an average of 195 days to reach a decision - up from 123 days historically. Manufacturers should account for longer review timelines in current project planning.

JXG devices are reviewed by the Neurology panel. Browse all Neurology devices →