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

    NAMIC ARIA(TM) INFLATION DEVICE

    K Number: K940542 · Decision Apr 18, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    55
    Applicant Total
    72
    Review Days
    70

    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
    NAMIC ARIA(TM) INFLATION DEVICE
    K Number
    K940542
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5470
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    American Medical Systems, Inc.
    Date Received
    February 7, 1994
    Decision Date
    April 18, 1994
    Product Code
    EZN
    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
    EZN Dilator, Catheter, Ureteral

    Similar 510(k) Clearances

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

    Optilume® High Pressure Urological Balloon Dilation Catheter

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

    ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter

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

    In-Ka Ureteral Balloon Dilatation Catheter

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

    EQUINOX Balloon Dilatation Catheter

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

    Ureteral Dilator Sets, Ureteral Dilators

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

    Safety Wire Guide Introducer

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

    Other Clearances by American Medical Systems, Inc.

    K Number Device Name
    K132655 RETROARC RETROPUBIC SLING SYSTEM
    K112842 AMS ELEVATE PC
    K100807 MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191
    K092735 GREENLIGHT XPS LASER SYSTEM
    K090934 PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM
    K090663 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
    K090713 ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP
    K082677 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
    K082730 AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE
    K082006 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
    Search all 72 clearances from American Medical Systems, Inc. →