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 Medtronic Neurosurgery and Aesculap, Inc..

3
Total
3
Cleared
97d
Avg days
2021
Since

List of Shunt, Central Nervous System And Components devices cleared through 510(k)

3 devices
1–3 of 3
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 Sep 16, 2021
StrataMR II Valves and Shunts
K212641
Medtronic Neurosurgery
Neurology · 27d

How to use this database

This page lists all FDA 510(k) submissions for Shunt, Central Nervous System And Components devices (product code JXG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Neurology FDA review panel. Browse all Neurology devices →