SFD

In Situ Polymerizing Peripheral Nerve Repair Device

Product code
SFD
Device name
In Situ Polymerizing Peripheral Nerve Repair Device
Device class
Class 2
21 CFR
21 CFR 882.5270
Medical specialty
Neurology
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
2

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-09-08.

NumberDecision dateApplicantDevice nameSummary
K2519572025-09-08Tissium SACoaptium Connect with Tissium LightPDF
DEN2400662025-06-17Tissium SACOAPTIUM Connect with TISSIUM LIGHT

1 summaries are archived here for direct download.

Official FDA classification page: SFD
Classification and pathway per current FDA publications. Data from openFDA (CC0).