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

    ENDOSCOPIC STAPLE REMOVAL INSTRUMENT

    K Number: K010620 · Decision May 17, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    77

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    Basic Information

    Device Name
    ENDOSCOPIC STAPLE REMOVAL INSTRUMENT
    K Number
    K010620
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Onux Medical, Inc.
    Date Received
    March 1, 2001
    Decision Date
    May 17, 2001
    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 Onux Medical, Inc.

    K Number Device Name
    K023372 NON-BIOABSORBABLE STAPLE
    K022777 MANUAL TOUCHE SYSTEM
    K014286 SALUTE, MODEL 3022
    K003522 SALUTE