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 Integra Lifesciences Production Corporation, Medtronic Neurosurgery and Sophysa.
FDA 510(k) Cleared Shunt, Central Nervous System And Components Devices (Product Code JXG)
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 Review Time
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 →