Product code SBG

Device name

In Situ Polymerizing Peripheral Nerve Cap

Medical specialty

Neurology

Device class

2

Regulation number

882.5260

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 cap is a prescription use only device composed of precursor materials that polymerize when delivered to the end of a peripheral nerve to function as a physical barrier to the surrounding in vivo environment to reduce the risk of formation of a symptomatic neuroma.

Source

FDA openFDA device classification dataset