510(k) Report

Devices descending from K103412

6 later devices reach Axiom Fascial Closure System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132362Weck Efx Endo Fascial Closure SystemTeleflexmedical, Inc.20135—
+2K253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ…Medical Impact20260—
+2K213271MedicloseTM SystemHealth Value Creation B.V., Trading AS Corporis Medical20230—
+2K172666CrossBow Fascial Closure System, CrossBow Fascial Closure System with AdaptorSutureease, Inc.20170—
+2K160117AbClose - Port Site Closure DeviceMedeon Biodesign, Inc.20161—
+3K193652AbClose - Port Site Closure DeviceMedeon Biodesign, Inc.20200—