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

    HSW LAPAROSCOPE AND ACCESSORIES

    K Number: K941967 · Decision May 16, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    6
    Review Days
    24

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    Basic Information

    Device Name
    HSW LAPAROSCOPE AND ACCESSORIES
    K Number
    K941967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Henke-Sass, Wolf GmbH
    Date Received
    April 22, 1994
    Decision Date
    May 16, 1994
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Henke-Sass, Wolf GmbH

    K Number Device Name
    K173070 HSW Resection Instruments
    K171336 Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
    K101547 HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET)
    K952186 HSW GMBH HYSTEROSCOPES & ACCESSORIES
    K943624 ELMED PNEUMOPERITONEUM NEEDLES