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

    SOLOS FAN RETRACTORS

    K Number: K925824 · Decision Mar 1, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    13
    Review Days
    104

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    Basic Information

    Device Name
    SOLOS FAN RETRACTORS
    K Number
    K925824
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Birtcher Medical Systems, Inc.
    Date Received
    November 17, 1992
    Decision Date
    March 1, 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 Birtcher Medical Systems, Inc.

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    K930887 BIRTCHER BRONCHUS & LUNG CLAMP (GS-1620 & GS-1600)
    K931771 BIRTCHER ENDOSCOPIC CORKSCREW
    K931654 BIRTCHER MAGNETIC RETRIEVER (GS-3100)
    K932987 BIRTCHER LAPAROSCOPE AND ACCESSORIES
    K936114 BIRTCHER PERICARDIAL KNIVES
    K930302 BIRTCHER SURE CLEAN INSTRUMENT SYSTEM
    K933319 BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM
    K930496 GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS
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