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510(k) K162741

AxoGuard Nerve Connector by Cook Biotech Incorporated — Product Code JXI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 2016
Date Received
September 30, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cuff, Nerve
Device Class
Class II
Regulation Number
882.5275
Review Panel
NE
Submission Type

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  • K232029 — VersaWrap Nerve Protector (November 2, 2023)
  • K231708 — Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Ax (October 12, 2023)