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

    MIST REDUCER SLEEVES

    K Number: K951398 · Decision May 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    6
    Review Days
    36

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    Basic Information

    Device Name
    MIST REDUCER SLEEVES
    K Number
    K951398
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Minimally Invasive Surgical Technologies, Inc.
    Date Received
    March 28, 1995
    Decision Date
    May 3, 1995
    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 Minimally Invasive Surgical Technologies, Inc.

    K Number Device Name
    K931273 MIST FORCEPS/CLAMPS FOR LAPAROSCOPOIC/ENDOSCOPIC
    K931275 MIST MICROSURGICAL MONOPOLAR FORCEPS
    K931274 MIST MICROSURGICAL MONOPOLAR SCISSORS
    K931272 MIST SCISSORS FOR LAPAROSCOPIC/ENDOSCOPIC PROCEDUR
    K931276 MIST RATCHETED FORCEPS FOR LAPAROSCOPIC/ENDOSCOPIC