SBG — In Situ Polymerizing Peripheral Nerve Cap Class II
Classification Details
- Product Code
- SBG
- Device Class
- Class II
- Regulation Number
- 882.5260
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
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.