FDA Product Code SFD: In Situ Polymerizing Peripheral Nerve Repair Device
An In Situ Polymerizing Peripheral Nerve Repair Device Is Intended For The Sutureless Repair Of Peripheral Nerve Injuries.
Leading manufacturers include Tissium SA.
2
Total
1
Cleared
142d
Avg days
2025
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared In Situ Polymerizing Peripheral Nerve Repair Device Devices (Product Code SFD)
2 devices
Cleared
Sep 08, 2025
Coaptium Connect with Tissium Light
Tissium SA
Neurology
75d
Not Cleared
Jun 17, 2025
COAPTIUM Connect with TISSIUM LIGHT
Tissium SA
Neurology
208d
About Product Code SFD - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code SFD since 2025, with 1 receiving FDA clearance (average review time: 142 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.
SFD devices are reviewed by the Neurology panel. Browse all Neurology devices →