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

    10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT

    K Number: K932805 · Decision Aug 16, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    10
    Review Days
    68

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    Basic Information

    Device Name
    10.0MM SUCTION/IRRIGATION PROBE & TUBING KIT
    K Number
    K932805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mayaguez Medical Center
    Date Received
    June 9, 1993
    Decision Date
    August 16, 1993
    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 Mayaguez Medical Center

    K Number Device Name
    K932804 IRRIGATING TAPERED PROBE
    K931950 POOLE TIP SUCTION PROBE
    K932806 POOLE TIP SUCTION PROBE & TUBING KIT
    K931856 5.0 MM IRRIGATION/ASPIRATION PROBE
    K931854 ENDOSCOPIC BLUNT DISSECTING INSTRUMENT
    K931912 IRRIGATING BLUNT DISSECTOR
    K931707 ENDOSCOPIC CABLE/WIRE COVER
    K931706 ENDOSCOPIC CABLE DRAPE
    K931705 ENDOSCOPIC INSTRUMENT HOLDER