Search Results
Found 1 results
510(k) Data Aggregation
K Number
K233322Device Name
Mochida Nerve Cuff
Manufacturer
Mochida Pharmaceutical Co., Ltd.
Date Cleared
2024-06-21
(266 days)
Product Code
JXI
Regulation Number
882.5275Why did this record match?
Applicant Name (Manufacturer) :
Mochida Pharmaceutical Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Mochida Nerve Cuff is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Device Description
The Mochida Nerve Cuff is made from a polyglycolic acid (PGA) sheet embedded into covalently cross-linked alginate gel, which is produced into a sponge form by freeze-drying and pressing into sheets.
The device is designed to repair peripheral nerve function by supporting the extension of the axon by providing a scaffold for growth of axons and Schwann cells following the degradation/absorption process after nerve injury. The device is to be implanted to cover the damaged, severed or excised section of the nerve axons.
When used, the device is cut according to the size of the nerve axon injury site, and fixed in place to cover the site.
Ask a Question
Page 1 of 1