510(k) Report

Devices descending from K871216

5 later devices reach Hilaris-Nori Endometrial Applicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc.20200—
+1K993472Segmented Vaginal ApplicatorMick Radio-Nuclear Instruments, Inc.20001—
+1K980576Varian Endometrial Applicator for Varisource Remote High Dose Rate AfterloaderVarian Medical Systems, Inc.19982—
+2K232623Universal Endometrial Applicator Set (GM11009840)Varian Medical Systems, Inc.20240—
+2K160021Varian Sterilization BoxesVarian Medical Systems, Inc.20160—