510(k) Report

Devices descending from K132660

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20232—
+1K210665Nerve TapeBiocircuit Technologies, Incorporated20221—
+1K202234NervAlign Nerve CuffRenerve, Ltd.20220—
+2K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc.20250—
+2K233533NerveTapeBiocircuit Technologies, Inc.20240—
+2K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation20230—