BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    Kitazato OPU Needles

    K Number: K162881 · Decision Jul 11, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    31
    Applicant Total
    11
    Review Days
    270

    Basic Information

    Device Name
    Kitazato OPU Needles
    K Number
    K162881
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6100
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kitazato Corporation
    Date Received
    October 14, 2016
    Decision Date
    July 11, 2017
    Product Code
    MQE
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQE Needle, Assisted Reproduction

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MQE), ordered by most recent decision date.

    VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Wallace Dual Lumen Oocyte Recovery System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Wallace Dual Lumen Oocyte Recovery System

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Single Lumen Ovum Aspiration Needles

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Kitazato Corporation

    K Number Device Name
    K200249 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])
    K193522 iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHA
    K192845 Sperm Freeze, Sperm Fridge
    K192540 Kitazato ET Catheters
    K190199 SepaSperm Washing Solution, SepaSperm Solution
    K181469 Cryotop®US-flash and Cryotop®US-scoop
    K182002 Cumulus Remover
    K171748 Vitrification Kit and Thawing Kit
    K162878 Kitazato ET Catheters
    K162667 Kitazato IUI Catheter
    Search all 11 clearances from Kitazato Corporation →