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

    DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER

    K Number: K884915 · Decision Oct 4, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    84
    Applicant Total
    12
    Review Days
    310

    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
    DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER
    K Number
    K884915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1620
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Dantec Electronics, Inc.
    Date Received
    November 28, 1988
    Decision Date
    October 4, 1989
    Product Code
    FAP
    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
    FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device

    Similar 510(k) Clearances

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

    SIGNAL GEAR URETHRAL CATHETER ELECTRODE

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

    SINGLE CHANNEL UROLOGICAL PRESSURE GAUGE, DUAL CHANNEL UROLOGICAL PRESSURE GAUGE

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

    URODYNAMIC ANALYSIS MODULE

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

    RUSCH URODYNAMIC RECTAL BALLOON 2-WAY CATHETER

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

    SCHUSTER DISPOSABLE BALLOON PROBE

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

    UROLAB SPECTRUM

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

    Other Clearances by Dantec Electronics, Inc.

    K Number Device Name
    K895460 CONCENTRIC ELECTRODE TYPE #13R01, 13R02
    K894911 SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118
    K881915 DANTEC MAGNETIC STIMULATOR
    K874758 DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE
    K874759 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE
    K874735 DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE
    K870567 EVOPORT 300
    K872106 DANTEC COUNTERPOINT
    K860368 URDYN 5000 (UROFLOWMETER)
    K853119 URODYN 1000
    Search all 12 clearances from Dantec Electronics, Inc. →