FDA.reportPublic FDA data

De Novo DEN240066

Device
COAPTIUM Connect with TISSIUM LIGHT
Contact
clara defraye
De Novo number
DEN240066
Product code
SFD
Regulation
882.5270
Classification name
in situ polymerizing peripheral nerve repair device
Decision
granted (DENG)
Decision date
2025-06-17
Date received
2024-11-21
Classification advisory
Neurology
Review advisory
Neurology
Type
Direct

Current FDA Classification#

Product code
SFD
Device name
In Situ Polymerizing Peripheral Nerve Repair Device
Medical specialty
Neurology
Device class
2
Regulation
882.5270
Implant
Y
Life sustain/support
N