Product code SFD

Device name

In Situ Polymerizing Peripheral Nerve Repair Device

Medical specialty

Neurology

Device class

2

Regulation number

882.5270

Review panel

NE

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

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

Source

FDA openFDA device classification dataset