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

    TRANSCERVICAL INTRAUTERINE KIT

    K Number: K914387 · Decision Dec 30, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    7
    Review Days
    90

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    Basic Information

    Device Name
    TRANSCERVICAL INTRAUTERINE KIT
    K Number
    K914387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.2700
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Telos Medical Corp.
    Date Received
    October 1, 1991
    Decision Date
    December 30, 1991
    Product Code
    HGS
    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
    HGS Catheter, Intrauterine And Introducer

    Similar 510(k) Clearances

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

    INTRAUTERINE CATHETER SET

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

    Other Clearances by Telos Medical Corp.

    K Number Device Name
    K920375 DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER
    K920044 DUAL LUMEN TRANSCERIVICAL INTRAUTERINE KIT
    K905018 LAB-SITE SAFETY NEEDLE
    K905017 LAB-SITE
    K882224 ULTRANS DISPOSABLE INTRAUTERINE
    K883832 CATHETER, INTRAUTERINE AND INTRODUCER