510(k) Report

Devices descending from K090429

10 later devices reach Nunc Ivf Centerwell and Icsi Dishes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123641Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish…Hertart20131—
+1K112413RI MSC (Migration Sedimentation Chamber)Research Instruments, Ltd.20127—
+2K150756Micro well group culture dish, 9-well; Micro well group culture dish, 16-wellHertart20150—
+2K133295QualisMenicon Co., Ltd. New Business Division20145—
+2K112644Seaforia Sperm Separation Assistance SystemLotus Bio, Ltd.20120—
+3K173075ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Dxnow, Inc.20184—
+4K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation20250—
+4K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount Aps20250—
+4K232980SpermAlign Sperm Separation DeviceCytoswim, Ltd.20240—
+4K221810LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceBonraybio Co., Ltd.20220—