510(k) Report

Devices descending from K181387

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

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