510(k) Report

Devices descending from K031069

10 later devices reach Surgisis Nerve Cuff through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162741AxoGuard Nerve ConnectorCook Biotech Incorporated20162—
+1K130557Neuragen 3DIntegra LifeSciences Corporation20141—
+1K132660Nerve CuffCook Biotech Incorporated20146—
+2K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20232—
+2K210665Nerve TapeBiocircuit Technologies, Incorporated20221—
+2K202234NervAlign Nerve CuffRenerve, Ltd.20220—
+2K163457NeuraGen 3D Nerve Guide MatrixIntegra LifeSciences Corporation20170—
+3K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.20250—
+3K233533NerveTapeBiocircuit Technologies, Inc.20240—
+3K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20230—