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

    ASI CYSTOLASE LASER CYSTOSCOPE

    K Number: K930361 · Decision Apr 29, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    9
    Review Days
    93

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    Basic Information

    Device Name
    ASI CYSTOLASE LASER CYSTOSCOPE
    K Number
    K930361
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Surgical Intervention, Inc.
    Date Received
    January 26, 1993
    Decision Date
    April 29, 1993
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by Advanced Surgical Intervention, Inc.

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    K902585 UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER
    K901336 ASI HEMOSTASIS CATHETER
    K896713 ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.
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