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

    DISSECTORS, FORCEPS, SCISSORS, DILATION SETS, AND GALL STONE COLLECTORS

    K Number: K936262 · Decision Jul 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    6
    Review Days
    183

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    Basic Information

    Device Name
    DISSECTORS, FORCEPS, SCISSORS, DILATION SETS, AND GALL STONE COLLECTORS
    K Number
    K936262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medicon Instruments, Inc.
    Date Received
    December 30, 1993
    Decision Date
    July 1, 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 Medicon Instruments, Inc.

    K Number Device Name
    K936249 MEDICON INSTRUMENTS UNIPOLAR COAGULATION ELECTRODES
    K936246 MEDICON INSTRUMENTS BIPOLAR FORCEPTS AND ELECTRODES
    K936247 MEDICON INSTRUMENTS TROCARS, TROCAR SLEEVES AND REDUCTION SLEEVES
    K936248 MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS
    K936250 RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK, PALPATION PROBE, KNOT GUIDE, ROEDER LOOP