FDA Product Code BSP: Needle, Conduction, Anesthetic (w/wo Introducer)
Under FDA product code BSP, anesthetic conduction needles — with or without introducers — are cleared for regional anesthesia and nerve block procedures.
These specialized needles are designed to deposit local anesthetic adjacent to specific nerves or nerve plexuses, producing regional anesthesia for surgery or pain management. They are available in a range of gauges, lengths, and tip configurations optimized for different nerve block techniques.
BSP devices are Class II medical devices, regulated under 21 CFR 868.5150 and reviewed by the FDA Anesthesiology panel.
Leading manufacturers include PAJUNK GmbH Medizintechnologie, Becton, Dickinson and Company and Aerin Medical, Inc..
FDA 510(k) Cleared Needle, Conduction, Anesthetic (w/wo Introducer) Devices (Product Code BSP)
About Product Code BSP - Regulatory Context
510(k) Submission Activity
152 total 510(k) submissions under product code BSP since 1981, with 152 receiving FDA clearance (average review time: 185 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under BSP have taken an average of 145 days to reach a decision - down from 187 days historically, suggesting improved FDA processing for this classification.
BSP devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →