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U.S. Department of Health and Human Services

Product Classification

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Device in situ polymerizing peripheral nerve cap
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.
Physical State The device is a polymeric, sterile, absorbable, in situ formed, hydrogel cap composed of water and polyethylene glycol.
Technical Method The device is prepared and in situ polymerized at the time of the surgery to form a hydrogel via a chemical reaction. The hydrogel is then delivered around the end of a peripheral nerve within a temporary silicone mold.
Target Area Peripheral Nerves
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeSBG
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5260
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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