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..
2
Total
1
Cleared
199d
Avg days
2024
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
90d
recently vs 308d historically
FDA 510(k) Cleared In Situ Polymerizing Peripheral Nerve Cap Devices (Product Code SBG)
2 devices
Cleared
Sep 29, 2025
allay Nerve Cap (TL5515-1)
Tulavi Therapeutics, Inc.
Neurology
90d
Not Cleared
Jul 16, 2024
allay Nerve Cap
Tulavi Therapeutics
Neurology
308d
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 remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - SBG Product Code
Recent submissions under SBG have taken an average of 90 days to reach a decision - down from 308 days historically, suggesting improved FDA processing for this classification.
SBG devices are reviewed by the Neurology panel. Browse all Neurology devices →