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

    POWER-DRIVE, WISAP MODEL #7688PD/7688PD1

    K Number: K982515 · Decision Jan 19, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    9
    Review Days
    183

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    Basic Information

    Device Name
    POWER-DRIVE, WISAP MODEL #7688PD/7688PD1
    K Number
    K982515
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh
    Date Received
    July 20, 1998
    Decision Date
    January 19, 1999
    Product Code
    HET
    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
    HET Laparoscope, Gynecologic (And Accessories)

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    Other Clearances by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh

    K Number Device Name
    K031014 HI-FLO THERME PNEU 45, WISAP #7083, 7083V
    K011510 MULTI HI-FLO PNEU, WISAP #7080
    K992481 CO2-OP-PNEU COMPUTER, WISAP #7050C, #7050CF, #7050CMF
    K992513 THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
    K990662 DISPOSABLE HEATING TUBING SET #7642HSES
    K982518 AQUA PURATOR-BIOTHERM, WISAP MODEL # 1608
    K960640 S*E*M*M* SET FOR MOTO DRIVE WISAP #7689 SSM (MODIFICATION)
    K952508 FLOW-THERME, WISAP #7642