SBG

In Situ Polymerizing Peripheral Nerve Cap

Product code

SBG

Device name

In Situ Polymerizing Peripheral Nerve Cap

Device class

Class 2

21 CFR

21 CFR 882.5260

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 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.

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: 2025-09-29.

1 summaries are archived here for direct download.