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

    SPERMASSIST

    K Number: K022443 · Decision Aug 28, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    258
    Applicant Total
    12
    Review Days
    34

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    Basic Information

    Device Name
    SPERMASSIST
    K Number
    K022443
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.6180
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nidacon International AB
    Date Received
    July 25, 2002
    Decision Date
    August 28, 2002
    Product Code
    MQL
    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
    MQL Media, Reproductive

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    Other Clearances by Nidacon International AB

    K Number Device Name
    K131145 PROINSERT
    K092107 VITRIBLAST, THERMOBLAST, MODEL VB-010, TB-010
    K023206 SPERM CRYOPROTEC
    K011607 SPERMCATCH
    K012123 NIDOIL
    K011606 PURESPERM BUFFER
    K011346 READYSWIM
    K002630 PURESPERM WASH
    K002623 PURESPERM 40 AND PURESPERM 80
    K984172 MODIFICATION OF PURESPERM
    Search all 12 clearances from Nidacon International AB →