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

    BLADE, SCALPEL & BLADE, HANDEL

    K Number: K954536 · Decision Nov 29, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    73
    Applicant Total
    9
    Review Days
    61

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    Basic Information

    Device Name
    BLADE, SCALPEL & BLADE, HANDEL
    K Number
    K954536
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Access Surgical Intl., Inc.
    Date Received
    September 29, 1995
    Decision Date
    November 29, 1995
    Product Code
    OCZ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered

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    Other Clearances by Access Surgical Intl., Inc.

    K Number Device Name
    K953376 ACCESS POINT
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    K944974 ACCESS POINT
    K940587 FLEX-I-PORT
    K933192 ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST.
    K922424 ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM.
    K922423 ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM.
    K922425 ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM