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

    ACCESS POINT

    K Number: K944974 · Decision Nov 8, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    9
    Review Days
    28

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    Basic Information

    Device Name
    ACCESS POINT
    K Number
    K944974
    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
    October 11, 1994
    Decision Date
    November 8, 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 Access Surgical Intl., Inc.

    K Number Device Name
    K954536 BLADE, SCALPEL & BLADE, HANDEL
    K953376 ACCESS POINT
    K945545 ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMENTS
    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