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

    NO. 86500 - ENDOSCOPIC JET WASHER

    K Number: K892426 · Decision Jun 22, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    92
    Applicant Total
    14
    Review Days
    73

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    Basic Information

    Device Name
    NO. 86500 - ENDOSCOPIC JET WASHER
    K Number
    K892426
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Superior Healthcare Group, Inc.
    Date Received
    April 10, 1989
    Decision Date
    June 22, 1989
    Product Code
    OCX
    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
    OCX Endoscopic Irrigation/Suction System

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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
    K885339 FLOW THRU 16,18,20,22 FR REPLACE. GASTRO TUBE KIT
    Search all 14 clearances from Superior Healthcare Group, Inc. →