FDA product code SBG

In Situ Polymerizing Peripheral Nerve Cap

Neurology·Class 2·21 CFR 882.5260·Implantable
US regulatory classifications
US Product Code (FDA)
SBG
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.5260
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

In Situ Polymerizing Peripheral Nerve Cap is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.