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

    ENDOSCOPIC ELASTIC BAND LIGATOR

    K Number: K880648 · Decision Apr 6, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    87
    Registration Numbers
    87
    Same Product Code
    21
    Applicant Total
    14
    Review Days
    49

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    Basic Information

    Device Name
    ENDOSCOPIC ELASTIC BAND LIGATOR
    K Number
    K880648
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.4400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Superior Healthcare Group, Inc.
    Date Received
    February 17, 1988
    Decision Date
    April 6, 1988
    Product Code
    FHN
    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
    FHN Ligator, Hemorrhoidal

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    Other Clearances by Superior Healthcare Group, Inc.

    K Number Device Name
    K925530 INSTRUMENT WARMER
    K924764 OVERTUBE FOR ENDSCOPIC LIGATOR
    K905755 NON-STERILE PATIENT EXAMINATION GLOVES
    K903347 SODIUM CHLORIDE SOLUTION
    K904216 STERILE WATER SOLUTION CATALOG # 10000
    K903340 STERILE URETHRAL CATHETER PROCEDURE KITS
    K896321 NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
    K894676 STERILE LATEX EXAM GLOVES
    K891445 LATEX EXAMINATION GLOVES
    K892426 NO. 86500 - ENDOSCOPIC JET WASHER
    Search all 14 clearances from Superior Healthcare Group, Inc. →