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

    ENDOSCOPIC ANTI-FOG KIT, 100-302-00

    K Number: K933520 · Decision Aug 24, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    35

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    Basic Information

    Device Name
    ENDOSCOPIC ANTI-FOG KIT, 100-302-00
    K Number
    K933520
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Avail-Southwest Division
    Date Received
    July 20, 1993
    Decision Date
    August 24, 1993
    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 Avail-Southwest Division

    K Number Device Name
    K952678 STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KIT
    K950830 STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP
    K864158 THERMAPAD