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

    GI SUPPLY PARACENTESIS PUMP

    K Number: K970186 · Decision Feb 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    GI SUPPLY PARACENTESIS PUMP
    K Number
    K970186
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gi Supply
    Date Received
    January 17, 1997
    Decision Date
    February 14, 1997
    Product Code
    BTA
    Advisory Committee
    General, Plastic Surgery
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Gi Supply

    K Number Device Name
    K191923 EverLift Submucosal Lifting Agent
    K031360 GI SUPPLY BILIARY STENT
    K012411 HP-ONE
    K970187 RUNYON LARGE VOLUME PARACENTESIS KIT
    K944903 HP-FAST
    K931044 OXY-BLOC
    K915816 BITE BLOCK/MOUTHPIECE FOR ENDOSCOPY