FDA Product Code JXI: Cuff, Nerve
Leading manufacturers include Biocircuit Technologies, Inc., Alafair Biosciences and Celestray Biotech Company, LLC.,.
FDA 510(k) Cleared Cuff, Nerve Devices (Product Code JXI)
About Product Code JXI - Regulatory Context
510(k) Submission Activity
40 total 510(k) submissions under product code JXI since 1985, with 40 receiving FDA clearance (average review time: 167 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA Review Time
Recent submissions under JXI have taken an average of 138 days to reach a decision - down from 173 days historically, suggesting improved FDA processing for this classification.
JXI devices are reviewed by the Neurology panel. Browse all Neurology devices →