510(k) Report

Devices descending from K002383

5 later devices reach Cook Ivf Sperm Buffer, Cook Ivf Sperm Medium, and Cook Ivf Sperm Gradient Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152782Sydney Ivf Sperm Medium, Sydney Ivf Sperm Gradient Kit, Sydney Ivf SpermientWilliam A. Cook Australia Pty., Ltd.20154—
+2K190199SepaSperm Washing Solution, SepaSperm SolutionKitazato Corporation20193—
+3K212410VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient MediumShenzhen Vitavitro Biotech Co., Ltd.20221—
+3K192644GM501 SpermAir and GM501 SpermActiveHamilton Thorne Incorporated20200—
+4K241095ARTSMedia Semen Wash MediumArtsmedia Denmark Aps20240—