SBG — In Situ Polymerizing Peripheral Nerve Cap Class II
FDA product code SBG covers "In Situ Polymerizing Peripheral Nerve Cap", a Class II medical device regulated under 21 CFR 882.5260. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
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.