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SFD — In Situ Polymerizing Peripheral Nerve Repair Device Class II

FDA Device Classification

Classification Details

Product Code
SFD
Device Class
Class II
Regulation Number
882.5270
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
Yes

Definition

An in situ polymerizing peripheral nerve repair device is intended for the sutureless repair of peripheral nerve injuries.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251957tissiumCoaptium Connect with Tissium LightSeptember 8, 2025
DEN240066tissiumCOAPTIUM Connect with TISSIUM LIGHTJune 17, 2025