SBGClass IIImplant
In Situ Polymerizing Peripheral Nerve Cap
Neurology · 21 CFR 882.5260
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.
MDR events2All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances2All time
Recent MDR events
2 adverse event reports on file
Event type breakdown
Injury2
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
2 clearances for this product code