510(k) Report

Devices descending from K021839

5 later devices reach Aart Gluteal Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162624Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.20174—
+2K223051Pre-Formed Silicone BlockInternational Medical Devices, Inc.20230—
+2K181387Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.20193—
+3K200073AugMENTA Penile ImplantAugmenta, LLC20220—
+3K220760Pre-Formed Penile Silicone BlockInternational Medical Devices, Inc.20221—