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

    LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH

    K Number: K940141 · Decision May 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    8
    Review Days
    128

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    Basic Information

    Device Name
    LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH
    K Number
    K940141
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Micro-Medical Devices, Inc.
    Date Received
    January 11, 1994
    Decision Date
    May 19, 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 Micro-Medical Devices, Inc.

    K Number Device Name
    K003695 MICROSCOPE-STAINLESS STEEL/FIBER OPTIC: .5-2.6MM MODEL MMD 4500 SERIES AND 2.7-5.0MM MODEL MMD-4700 SERIES
    K983882 MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOSCOPE-POLYIMIDE,MODEL MMD-1400
    K963675 THE FLAT PANEL STEIRLE DRAPE SYSTEM(TM), VIDEO MONITOR STERILE DRAPE
    K951482 ENDOSCOPES, FIBER OPTIC LAPAROSCOPES, (STERILIZABLE)
    K951894 ACCESS EXPANSION SYSTEM
    K945656 THE COUPLER/DRAPE(TM), VIDEO CAMERA STERILE DRAPE
    K936213 ARTHROSCOPES AND ACCESSORIES