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

    BIRTCHER SURE CLEAN INSTRUMENT SYSTEM

    K Number: K930302 · Decision Oct 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    13
    Applicant Total
    13
    Review Days
    279

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    Basic Information

    Device Name
    BIRTCHER SURE CLEAN INSTRUMENT SYSTEM
    K Number
    K930302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Birtcher Medical Systems, Inc.
    Date Received
    January 21, 1993
    Decision Date
    October 27, 1993
    Product Code
    GCI
    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
    GCI Laryngoscope, Endoscope

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    Other Clearances by Birtcher Medical Systems, Inc.

    K Number Device Name
    K932779 BIRTCHER SWIVEL GRIP LAPAROSCOPIC PROBES & ACCESS.
    K944681 LECTROSURIGICAL, CUTTING AND COAGULATION AND ACCESSORIES
    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
    K933319 BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM
    K930496 GI-1090,1095,1080,1085,1086,1088, ENDO. CLAMPS
    K925824 SOLOS FAN RETRACTORS
    Search all 13 clearances from Birtcher Medical Systems, Inc. →