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

    FST CATH-UD CATHETER

    K Number: K905641 · Decision Feb 19, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    35
    Applicant Total
    11
    Review Days
    63

    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
    FST CATH-UD CATHETER
    K Number
    K905641
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Fiberoptic Sensor Technlogies, Inc.
    Date Received
    December 18, 1990
    Decision Date
    February 19, 1991
    Product Code
    FEN
    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
    FEN Device, Cystometric, Hydraulic

    Similar 510(k) Clearances

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

    CT3000Pro

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

    URONIRS, MODEL 2000

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

    LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY

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

    ACCUSET SENSOR, MODEL 2000

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

    NEURO URODYNAMIC SUITE, MODEL 9032E0101

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

    IN-PROBE II URODYNAMIC SYSTEM

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

    Other Clearances by Fiberoptic Sensor Technlogies, Inc.

    K Number Device Name
    K945753 FST FIBEROPTIC PRESSURE CONVERTER
    K950908 FST CATH-UD, CATHETER
    K945495 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION
    K930171 FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR
    K922776 FST COUNCIL TIP FOLEY CATHETER
    K922476 URO-PRO 2000
    K926088 FST CATH UD-DUAL DUAL PRESSURE CATHETER
    K913113 FST CATH-UD CATHETER, MODIFICATION
    K913721 FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM
    K864000 FST DISPOSABLE FIBER OPTIC TRANSDUCER #0100-00
    Search all 11 clearances from Fiberoptic Sensor Technlogies, Inc. →