BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device

    K Number: K221810 · Decision Oct 31, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    49
    Applicant Total
    5
    Review Days
    131

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    Basic Information

    Device Name
    LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device
    K Number
    K221810
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6160
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bonraybio Co., Ltd.
    Date Received
    June 22, 2022
    Decision Date
    October 31, 2022
    Product Code
    MQK
    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
    MQK Labware, Assisted Reproduction

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    Other Clearances by Bonraybio Co., Ltd.

    K Number Device Name
    K242830 LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer
    K242388 LensHooke X12 PRO Semen Analysis System
    K202089 LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer
    K180343 LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer