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

    BIRTCHER ENDOSCOPIC CORKSCREW

    K Number: K931771 · Decision Apr 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    13
    Review Days
    381

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    Basic Information

    Device Name
    BIRTCHER ENDOSCOPIC CORKSCREW
    K Number
    K931771
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Birtcher Medical Systems, Inc.
    Date Received
    April 9, 1993
    Decision Date
    April 25, 1994
    Product Code
    HET
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HET Laparoscope, Gynecologic (And Accessories)

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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)
    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
    K925824 SOLOS FAN RETRACTORS
    Search all 13 clearances from Birtcher Medical Systems, Inc. →