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

    BITOME(TM) BIPOLAR SPHINCTEROTOME

    K Number: K895842 · Decision Jan 11, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    187
    Applicant Total
    21
    Review Days
    101

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    Basic Information

    Device Name
    BITOME(TM) BIPOLAR SPHINCTEROTOME
    K Number
    K895842
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4300
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Everest Medical Corp.
    Date Received
    October 2, 1989
    Decision Date
    January 11, 1990
    Product Code
    KNS
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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    Other Clearances by Everest Medical Corp.

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    K971565 BICOAG COAGULATING FORCEPS
    K955001 EVERSHEARS SCISSORS, BILAP PROBES, BICOAG FORCEPS
    K945975 EVERSHEARS(R) SCISSORS, BILAP(R) PROBES, BICOAG(R) FORCEPS
    K922509 LAPAROSCOPIC ELECTROSURG DEVICE W/IRRIGA & ASPIRA
    K922246 TUBING SET W/ IRRIGATION & ASPIRATION VALVING
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