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

    KDF-2.3

    K Number: K894264 · Decision Aug 15, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    28
    Applicant Total
    10
    Review Days
    56

    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
    KDF-2.3
    K Number
    K894264
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.5250
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Unimar, Inc.
    Date Received
    June 20, 1989
    Decision Date
    August 15, 1989
    Product Code
    HDR
    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
    HDR Cap, Cervical

    Similar 510(k) Clearances

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

    Béa Applicator (BAP-GB-01)

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

    FERTI-LILY Conception Cup

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

    OVES CERVICAL CAP

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

    IMAGYN INTRAUTERINE INSEMINATION DEVICE

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

    COOK INSEMINATION CUP

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

    MINISPACE(TM) IUI CATHETER

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

    Other Clearances by Unimar, Inc.

    K Number Device Name
    K932432 KRONNER REINFORCING STYLETTE
    K920803 HSG TRAY
    K910317 UNI-SEM(TM)
    K904473 KRONNER MANIPUJECTOR
    K895659 HUI MINI-FLEX
    K895403 ASPIRETTE ENDOCERVICAL ASPIRATOR
    K890848 CERVEX-BRUSH
    K854415 ENDOMETRIAL PIPELLE
    K810291 STERILE/DISPOSABLE HSG TRAY