SBG · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5260
Classification
FDA Product Code
SBG
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.5260
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.