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

    ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM

    K Number: K922425 · Decision Nov 17, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    9
    Review Days
    180

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    Basic Information

    Device Name
    ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM
    K Number
    K922425
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Access Surgical Intl., Inc.
    Date Received
    May 21, 1992
    Decision Date
    November 17, 1992
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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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
    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.