BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540

    K Number: K022643 · Decision Nov 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    25
    Applicant Total
    4
    Review Days
    89

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    Basic Information

    Device Name
    BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540
    K Number
    K022643
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6130
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Swemed Lab International AB
    Date Received
    August 8, 2002
    Decision Date
    November 5, 2002
    Product Code
    MQH
    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
    MQH Microtools, Assisted Reproduction (Pipettes)

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    Other Clearances by Swemed Lab International AB

    K Number Device Name
    K053208 CLEAR VISION EMBRYO TRANSFER CATHETER SET, MODEL B100000 - B 100007; CLEAR VISION TRIAL TRANSFER CATHETER SET
    K991273 SWEMED FOLLICLE ASPIRATION SET, DOUBLE LUMEN, SINGLE LUMEN, AND LUER NEEDLE
    K991700 SWEMED INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES; HOLDING PIPTTES; DENUDING PIPETTES; ASSISTED/ZO