510(k) Report

Devices descending from K162624

4 later devices reach Pre-Formed Penile Silicone Block through their predicates, nearest generation first.

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