510(k) Report

Devices descending from DEN130036

8 later devices reach Prostate Immobilizer Rectal Balloon through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223249Pro-Tx Endorectal Balloon (PROT-25)Dxtx Medical, Inc.20230—
+1K150234Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301Myriad Medical, LLC20151—
+1K141958Erb Endorectal BalloonEdge Medical, LLC20140—
+1K141154Oartrac SystemRadiadyne20143—
+2K180478RectalPro 75 Endorectal BalloonQlrad International, Ltd.20180—
+2K162954OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC20171—
+2K150719OARtrac System with Skin SensorsRadiadyne, LLC20152—
+3K182395OARtrac SystemRadialdyne, LLC201905