510(k) Report

Devices descending from K980601

18 later devices reach Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081677Savi Applicator KitCianna Medical, Inc.200811—
+1K070659Biolucent Applicator KitBiolucent, Inc.200713—
+1K061241Biolucent Applicator, Model Rta-XXBiolucent, Inc.200617—
+2K092822Capri ApplicatorVivaray, Inc.20092—
+2K092405Mammosite Multi LumenHologic, Inc.20090—
+2K091378Mammosite II Radiation Therapy SystemHologic, Inc.20099—
+2K080565Modification to: Savi Applicator KitCianna Medical, Inc.200812—
+3K133922Gentlecare AR ApplicatorGc Medtech, LLC20140—
+3K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc.201282
+3K120344Radiapak Brachytherapy Applicator Balloon DeviceRadiadyne, LLC (Specification Developer)20120—
+4K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical…Carl Zeiss Meditec, AG20250—
+4K162568Intrabeam 600Carl Zeiss Meditec, AG20161—
+4K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+5K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+6K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+7K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—
+7K182665Sensus TPS WorkstationSensus Healthcare, Inc.20190—
+7K180308PreludeMedcom GmbH20180—