510(k) Report

Devices descending from K002385

9 later devices reach Cook Ivf Follicle Flushing Buffer, Cook Ivf Oocyte Wash Buffer, Cook Ivf… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170498Gems Oocyte Retrieval Buffer ORB-20, ORB-50Genea Biomedx Pty, Ltd.20170—
+1K153290Sydney IVF Follicle Flush Buffer, Sydney IVF Fertilization Medium, Sydney IVF Cleavage…William A. Cook Australia Pty., Ltd.20166—
+1K133912Origio Sequential Fert, Origio Sequential Fert with Phenol Red, Origio Sequential Cleav…Origio A/S20140—
+2K231370Dewin Blastocyst Medium (with HSA and without HSA)Donnevie Medical Technology (Shanghai) Co., Ltd.20230—
+2K212426Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and…Donnevie Medical Technology (Shanghai) Co., Ltd.20220—
+2K200249Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA]…Kitazato Corporation20200—
+2K200408VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing…Shenzhen Vitavitro Biotech Co., Ltd.20201—
+2K161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst…Genea Biomedx Pty, Ltd.20170—
+3K251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle…Donnevie Medical Technology (Shanghai) Co., Ltd.20250—