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

    HSW Resection Instruments

    K Number: K173070 · Decision Jun 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135
    Same Product Code
    170
    Applicant Total
    6
    Review Days
    252

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    Basic Information

    Device Name
    HSW Resection Instruments
    K Number
    K173070
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1690
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Henke-Sass, Wolf GmbH
    Date Received
    September 29, 2017
    Decision Date
    June 8, 2018
    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 Henke-Sass, Wolf GmbH

    K Number Device Name
    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
    K941967 HSW LAPAROSCOPE AND ACCESSORIES