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

    ACMI RIGI-FLEX NEPHORSCOPE

    K Number: K791182 · Decision Jul 30, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    9
    Applicant Total
    9
    Review Days
    35

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    ACMI RIGI-FLEX NEPHORSCOPE
    K Number
    K791182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    American Cystocope Makers, Inc.
    Date Received
    June 25, 1979
    Decision Date
    July 30, 1979
    Product Code
    FGA
    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
    FGA Kit, Nephroscope

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (FGA), ordered by most recent decision date.

    Percutaneous Nephroscope System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by American Cystocope Makers, Inc.

    K Number Device Name
    K832040 STERILE FLUID PRODUCING UNIT #EP550
    K812637 ACMI BIPOLAR HEMOSTATIC SOURCE
    K811218 ACMI ASPIRATOR KIT #8808
    K803214 ACMI BIPOLAR HEMOSTATIC ELECTRODE
    K770754 DUODENOSCOPE, MOLEL TX-6
    K760822 MODEL TX-8 PANENDOSCOPE
    K760452 COLONOSCOPE, 2-CHANNEL LOG (ACMI TX-92)
    K760451 AIR WATER SOURCE (ACMI MODEL 710)