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

    5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH

    K Number: K992402 · Decision Dec 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    22
    Review Days
    156

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    Basic Information

    Device Name
    5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 FRENCH X 200CM X 35MM TIP TAPER-30MM CUTTING WIRE, 5.0 FRENCH
    K Number
    K992402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Telemed Systems, Inc.
    Date Received
    July 19, 1999
    Decision Date
    December 22, 1999
    Product Code
    KNS
    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
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    Other Clearances by Telemed Systems, Inc.

    K Number Device Name
    K020379 PPD BALLOON DILATATION CATHETER
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    K010412 FLEXIBLE ENDOSCOPIC SCISSORS
    K992390 HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATED 160 CM OVAL CUP, HOT BIOPSY FORCEPS SERRATD
    K974312 REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVAL CUP W/NEEDLE, REUSABLE BIOPSY FORCEPS SERRATED CUP, REUSAR
    K974300 TELEMED SYSTEMS RETRIEVAL BASKET
    K901435 GASTROINTESTINAL CYTOLOGY BRUSH
    K901427 BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
    K901425 PYLORIC BALLOON DILATOR
    K901424 ESOPHAGEAL BALLOON DILATOR
    Search all 22 clearances from Telemed Systems, Inc. →