BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0

    K Number: K031974 · Decision Sep 29, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    5
    Review Days
    95

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    Basic Information

    Device Name
    ASAP HYSTEROSCOPE AND GYNECOLOGIC LAPAROSCOPE (SURGERY) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0
    K Number
    K031974
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Asap Endoscopic Products GmbH
    Date Received
    June 26, 2003
    Decision Date
    September 29, 2003
    Product Code
    HIH
    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
    HIH Hysteroscope (And Accessories)

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    Other Clearances by Asap Endoscopic Products GmbH

    K Number Device Name
    K121261 ASAP MUITISCOPE
    K032822 ASAP SINUSCOPE 10-0036-00,10-0037-00,10-0038,10-0039-00,10-0040-00,10-0041-00,10-0042-00,10-0043-00,10-0044-00,10-0045-0
    K031972 ASAP ARTHROSCOPE MODELS; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00,
    K031141 ASAP CYSTOSCOPE; ASAP LAPAROSCOPE; ASAP LARYGOSCOPE; ASAP OESOPHAGOSCOPE