510(k) Report

Devices descending from K913908

5 later devices reach Omnitron Gyn Applicator System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063381CT Compatible F/S/D ApplicatorsMick Radio-Nuclear Instruments, Inc.20061—
+1K955844Applicators for Varian Varisource Remote High Dose Rate AfterloaderVarian Assoc., Inc.19964—
+2K200221CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators…Mick Radio-Nuclear Instruments, Inc.20200—
+2K172675Varian Cervical SleevesVarian Medical Systems, Inc.20180—
+2K033828CT Compatible Intrauterine Sleeves, Cat #0311, 9406Mick Radio-Nuclear Instruments, Inc.20040—