FDA Product Code SBG: In Situ Polymerizing Peripheral Nerve Cap
An In Situ Polymerizing Peripheral Nerve Cap Is A Prescription Use Only Device Composed Of Precursor Materials That Polymerize When Delivered To The End Of A Peripheral Nerve To Function As A Physical Barrier To The Surrounding In Vivo Environment To Reduce The Risk Of Formation Of A Symptomatic Neuroma.
Leading manufacturers include Tulavi Therapeutics and Tulavi Therapeutics, Inc..
FDA 510(k) Cleared In Situ Polymerizing Peripheral Nerve Cap Devices (Product Code SBG)
About Product Code SBG - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SBG since 2024, with 1 receiving FDA clearance (average review time: 199 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
SBG devices are reviewed by the Neurology panel. Browse all Neurology devices →