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

    USA SERIES LAPAROSCOPES

    K Number: K013165 · Decision Jan 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    10
    Review Days
    119

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    Basic Information

    Device Name
    USA SERIES LAPAROSCOPES
    K Number
    K013165
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Circon Acmi
    Date Received
    September 21, 2001
    Decision Date
    January 18, 2002
    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 Circon Acmi

    K Number Device Name
    K980492 AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
    K905706 GYN-1500 HYSTEROSCOPIC INUFFLATOR
    K905705 LAP 3501 HIGH FLOW INSUFFLATOR
    K884097 MORRIS ANTI-SPLATTER DEVICE FOR ENDOSCOPES
    K884025 CIRCON ACMI BICAP II THERAPEUTIC SYSTEM BC-200
    K884254 CIRCON ACMI BICAP III THERAPEUTIC SYSTEM
    K884252 CIRCON ACMI BICAP HEMORRHOID SYSTEM BH-10 & BHP-20
    K884306 BICAP ABLATING FORCEPS BAF-7
    K883819 BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-P