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

    GENXCATHETER

    K Number: K963031 · Decision Oct 21, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    28
    Applicant Total
    8
    Review Days
    77

    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
    GENXCATHETER
    K Number
    K963031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Genx Intl., Inc.
    Date Received
    August 5, 1996
    Decision Date
    October 21, 1996
    Product Code
    MFD
    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
    MFD Cannula, Intrauterine Insemination

    Similar 510(k) Clearances

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

    INSEMINATION CATHETER, MODEL 320301

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

    THECURVE, ITEM 507

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

    `THE INSEMINATOR' (PROPOSED)

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

    MEDWORKS VISUALIZATION INSEMINATION CATHETER

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

    MEDWORKS INSEMINATION CATHETER

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

    EMBRYON INTRAUTERINE INSEMINATION CATHETER, EMRYON SOFT INTRAUTERINE INSEMINATION CATHETER, STYLET FOR EMBRYON INTRAUTER

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

    Other Clearances by Genx Intl., Inc.

    K Number Device Name
    K092963 GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3
    K092667 GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT
    K092578 LIFEGLOBAL PROTEIN SUPPLEMENT
    K083509 LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA
    K070689 LG SPERM FREEZING
    K020560 WORKBENCH BY <GENX>
    K962816 SPERM PREPARATION MEDIA