FDA 510(k) Applications Submitted by Kitazato Corporation
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K200249 |
02/03/2020 |
Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) |
Kitazato Corporation |
| K190199 |
02/04/2019 |
SepaSperm Washing Solution, SepaSperm Solution |
Kitazato Corporation |
| K181469 |
06/04/2018 |
Cryotop«US-flash and Cryotop«US-scoop |
Kitazato Corporation |
| K171748 |
06/13/2017 |
Vitrification Kit and Thawing Kit |
Kitazato Corporation |
| K182002 |
07/26/2018 |
Cumulus Remover |
Kitazato Corporation |
| K192540 |
09/16/2019 |
Kitazato ET Catheters |
Kitazato Corporation |
| K192845 |
10/03/2019 |
Sperm Freeze, Sperm Fridge |
Kitazato Corporation |
| K193522 |
12/19/2019 |
iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA |
Kitazato Corporation |
| K162667 |
09/26/2016 |
Kitazato IUI Catheter |
Kitazato Corporation |
| K162878 |
10/14/2016 |
Kitazato ET Catheters |
Kitazato Corporation |
| K162881 |
10/14/2016 |
Kitazato OPU Needles |
Kitazato Corporation |
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