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In Situ Polymerizing Peripheral Nerve Cap

FDA product code SBG · 1 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.5260
Review panel
NE
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-09-29 – 2025-09-29

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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