SBG

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

In Situ Polymerizing Peripheral Nerve Cap

Device class

Class II (moderate risk)

Regulation

21 CFR 882.5260

Medical specialty

Neurology

Flags

Implant

FDA 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.

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