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

    ECHOMARK INTRAUTERINE GUIDING CATHETER

    K Number: K932436 · Decision Nov 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    4
    Applicant Total
    6
    Review Days
    911

    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
    ECHOMARK INTRAUTERINE GUIDING CATHETER
    K Number
    K932436
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Echocath, Inc.
    Date Received
    May 19, 1993
    Decision Date
    November 16, 1995
    Product Code
    MOV
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MOV Catheters, Salpingography

    Similar 510(k) Clearances

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

    Modified Novy Cornual Cannulation Set

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    NOVY CORNUAL CANNULATION SET

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    OVAMED INTRAUTERINE ACCESS CATHETER

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology
    View all

    Other Clearances by Echocath, Inc.

    K Number Device Name
    K010482 ECHOFLOW PORTABLE DOPPLER BLOOD FLOW MEASUREMENT SYSTEM; MODEL PEF-1
    K990642 ECHOFLOW DOPPLER BLOOD VELOCITY METER
    K933417 ECHOMARK(R) ELECTROPHYSIOLOGY CATHETER
    K926351 COLORMARK(TM) VISUALIZATION SYSTEM
    K922787 ECHOMARK GUIDEWIRE WITH ULTRASONIC LOCALIZATION