In Situ Polymerizing Peripheral Nerve Cap
An in situ polymerizing peripheral nerve cap is a prescription implant device composed of precursor materials that polymerize when delivered to the end of a peripheral nerve, forming a physical barrier to the surrounding in vivo environment to reduce the risk of symptomatic neuroma formation following nerve injury or amputation. It is classified as FDA Class II (510(k) required) under regulation 882.5260 in the Neurology specialty, with product code SBG. The device is flagged as an implant, reflecting its permanent in vivo placement, though it does not support life-sustaining functions.
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Basic Information
- Product Code
- SBG
- Device Class
- FDA class 2
- Regulation Number
- 882.5260
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.