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

    ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM

    K Number: K963064 · Decision Jun 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    68
    Applicant Total
    5
    Review Days
    302

    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
    ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM
    K Number
    K963064
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1725
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Laborie Medical Tech Corp.
    Date Received
    August 7, 1996
    Decision Date
    June 5, 1997
    Product Code
    FFX
    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
    FFX System, Gastrointestinal Motility (Electrical)

    Similar 510(k) Clearances

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

    mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)

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

    Solar Compact (G4-1)

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

    EndoflipTM 300 System

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

    EndoflipTM 300

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

    Transit-Pellets

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

    IntraMarX 3D Radiopaque Marker

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

    Other Clearances by Laborie Medical Tech Corp.

    K Number Device Name
    K993721 UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
    K990041 UROSTYM BIOFEEDBACK AND STIMULATION PROBES
    K991479 VISER PENILE TUMESCENCE MONITOR
    K950016 CART, MODE NUMBER UDS-CART