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

    ENDOSCOPIC ELECTRODE

    K Number: K912656 · Decision Sep 16, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    13
    Review Days
    91

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    Basic Information

    Device Name
    ENDOSCOPIC ELECTRODE
    K Number
    K912656
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Applied Urology, Inc.
    Date Received
    June 17, 1991
    Decision Date
    September 16, 1991
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Applied Urology, Inc.

    K Number Device Name
    K921838 ACUCISE URETERAL CUTTING CATHETER
    K925282 UROLOGICAL CATHETER AND ACCESSORIES
    K920695 URETERAL STENT
    K915219 URETHRAL ELECTRODE SHEATH
    K912093 DISPOSABLE ASPIRATION IRRIGATION SYSTEM
    K920030 SURESEAL ENDOSCOPIC VALVE
    K912903 PERCUTANEOUS RETRACTOR KIT
    K905731 FLEXIBLE ENDOSCOPIC ELECTRODE
    K903994 URETEROPYELOGRAM CATH FOR RETROGRADE DYE INJECTION
    K901214 RIGID URETEROSCOPE
    Search all 13 clearances from Applied Urology, Inc. →