510(k) Report

Devices descending from K081116

2 later devices reach G-Ivf G5 Series through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K202862Gx-IVF, Gx-TL, Gx-MOPS PLUSVitrolife Sweden AB20210—
+1K153478Sydney IVF Gamete BufferWilliam A. Cook Australia Pty., Ltd.20160—