510(k) Report

Devices descending from K133568

4 later devices reach G-TL through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202862Gx-IVF, Gx-TL, Gx-MOPS PLUSVitrolife Sweden AB20210—
+1K1910631-Step Culture MediumShenzhen Vitavitro Biotech Co., Ltd.20191—
+1K161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst…Genea Biomedx Pty, Ltd.20170—
+2K193285V-OnestepVitromed GmbH20200—