510(k) Report

Devices descending from K082363

3 later devices reach Cook Sydney Ivf Blastocyst Vitrification (K-Sibv-5000), Warming (K-Sibw-5000)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143724COOK Sydney IVF Blastocyst Vitrification Kit, COOK Sydney IVF Blastocyst Warming KitWilliam A. Cook Australia Pty., Ltd.20152—
+2K162409Gems Vitrification Set, Gems Warming SetGenea Biomedx Pty, Ltd.20170—
+2K161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst…Genea Biomedx Pty, Ltd.20170—