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

    TEFLON COATED RESECTOSCOPE SHEATH

    K Number: K761242 · Decision Dec 16, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    23
    Applicant Total
    41
    Review Days
    3

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    Basic Information

    Device Name
    TEFLON COATED RESECTOSCOPE SHEATH
    K Number
    K761242
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    V. Mueller O.V. Baxter Healthcare Corp.
    Date Received
    December 13, 1976
    Decision Date
    December 16, 1976
    Product Code
    FJL
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FJL Resectoscope

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    Other Clearances by V. Mueller O.V. Baxter Healthcare Corp.

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    K770959 BOUGIE, FILIFORM, JACKSON
    K770280 CORD, ELECTROSURGICAL-STERILE & DISPOS.
    K760851 CONVERSE ALTAR RETRACTOR
    K760273 LITHOTRITE
    K760172 OBTURATOR, VISUAL
    K760180 FORCEPS, GRASPING
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