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

    BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500

    K Number: K062438 · Decision Oct 27, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    57
    Applicant Total
    43
    Review Days
    67

    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
    BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500
    K Number
    K062438
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Ob/Gyn
    Date Received
    August 21, 2006
    Decision Date
    October 27, 2006
    Product Code
    KNA
    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
    KNA Instrument, Manual, Specialized Obstetric-Gynecologic

    Similar 510(k) Clearances

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

    PANPAC WORD/BARTHOLIN CATHETER

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

    COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)

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

    GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER

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

    COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400

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

    EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01

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

    TAMPONADE UTERINE BALLOON CATHETER SET

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

    Other Clearances by Cook Ob/Gyn

    K Number Device Name
    K030441 SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT
    K023850 SYDNEY IVF EMBRYO BIOPSY MEDIUM
    K013597 TAMPONADE UTERINE BALLOON CATHETER SET
    K002385 COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,
    K002383 COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT
    K983595 TRANSMYOMETRIAL EMBRYO TRANSFER SET
    K983596 INTRACYTOPLASMIC SPERM INJECTION (ICSI) MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, ASSISTED HATCHING
    K983642 COOK MINI-INCUBATOR
    K983593 OVUM PICK-UP ASPIRATION NEEDLES
    K983591 INTRATUBAL TRANSFER SETS
    Search all 43 clearances from Cook Ob/Gyn →