510(k) Report

Devices descending from K042603

6 later devices reach Gynecare Prolene Fastener System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120831AnchorsureNeomedic International S.L.20125—
+2K220420Saffron Fixation SystemColoplast A/S20220—
+2K160569NeuGuidePop Medical Solutions201631
+3K213783ApyxEscala Medical20222—
+4K230730ApyxEscala Medical20231—
+5K260380MenditEscala Medical, Ltd.20260—