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

    USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8

    K Number: K023358 · Decision Jan 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    120
    Registration Numbers
    120
    Same Product Code
    112
    Applicant Total
    16
    Review Days
    88

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    Basic Information

    Device Name
    USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8
    K Number
    K023358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acmi Corporation
    Date Received
    October 7, 2002
    Decision Date
    January 3, 2003
    Product Code
    FGB
    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
    FGB Ureteroscope And Accessories, Flexible/Rigid

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    Other Clearances by Acmi Corporation

    K Number Device Name
    K061975 PLASMASEAL OPEN FORCEPS, MODELS 2103PK AND 91701PK
    K060752 ACMI DUR-HL LASER SYSTEMS
    K060269 ACMI DUR-DIGITAL URETEROSCOPE AND CHOLEDOCHOSCOPE SYSTEM
    K051593 UROPASS URETERAL ACCESS SHEATH, MODEL 61224
    K052044 ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
    K043581 DUAL LUMEN CATHETER
    K042069 INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM
    K042225 ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
    K031758 ACMI M4 TELESCOPES
    K030960 ECN ELECTRONIC VIDEO CYSTONEPHROSCOPE
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