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510(k) Data Aggregation
K Number
K210665Device Name
Nerve Tape
Manufacturer
BioCircuit Technologies, Incorporated
Date Cleared
2022-07-15
(497 days)
Product Code
JXI
Regulation Number
882.5275Why did this record match?
Applicant Name (Manufacturer) :
BioCircuit Technologies, Incorporated
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nerve Tape is indicated for the repair of peripheral nerve discontinuities where can be achieved by flexion of the extremity.
Device Description
The Nerve Tape device is composed of a bioabsorbable, extracellular collagen matrix derived from small intestinal submucosa (SIS). Microhooks made of a nickel-titanium alloy (NiTiNOL) are integrated into the nerve contacting side of the SIS for mechanical fixation and apposition of nerve ends. The device is packaged in a dried state and supplied sterile, and is rehydrated prior to use.
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