510(k) Report

Devices descending from K983594

14 later devices reach Embryo Transfer Catheters/Sets through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180302Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator…Cook Incorporated20180—
+1K173103Pivet and Soft-Pass Embryo Transfer Catheter SetsCook Incorporated20181—
+1K173686Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer CatheterCook Incorporated20181—
+1K172051Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo…Cook Incorporated20181—
+1K033084Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer CatheterPortex, Ltd.200356
+1K994327Embryon Transfer Catheters/SetsRocket Medical Plc20000—
+2K220010Daylily Single Use Sterile Embryo Transfer CatheterShanghai Horizon Medical Technology Co., Ltd.20220—
+2K192540Kitazato ET CathetersKitazato Corporation20200—
+2K191015Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter…Cook Incorporated20190—
+2K162878Kitazato ET CathetersKitazato Corporation20172—
+2K161547Transem and EchoGen Embryo Transfer CathetersOrigio A/S20170—
+2K162064CrossBay IVF Embryo Transfer Catheter SetCrossbay Medical, Inc.20170—
+3K253354Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C…Guangzhou Hehong Biotech Co., Ltd.20260—
+3K243373Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter -…Vitrolife Sweden AB20250—