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

    O. B. PACK IV

    K Number: K902032 · Decision Sep 28, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    10
    Applicant Total
    36
    Review Days
    147

    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
    O. B. PACK IV
    K Number
    K902032
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1050
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Applicant
    Customed, Inc.
    Date Received
    May 4, 1990
    Decision Date
    September 28, 1990
    Product Code
    HFC
    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
    HFC Aspirator, Endocervical

    Similar 510(k) Clearances

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

    ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR

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

    CERVICAL MUCOUS ASPIRATION CATHETER

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

    PEDI VAGINAL ASPIRATOR

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

    SELECTMUCUS

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

    ENDOCERVICAL ASPIRATOR

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

    OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)

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

    Other Clearances by Customed, Inc.

    K Number Device Name
    K974647 FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
    K971920 GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)
    K964011 SUCTION CATHETER TRAY PRODUCT NO. 900277
    K962652 URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)
    K962596 CUSTOMED BLOOD EXTRACTION KIT
    K961442 UNIVERSAL DRAINAGE TRAY
    K953678 STERIMED STERIZATION WRAPPER (NON-STERILE)
    K950295 WOUND CLOSURE/LACERATION TRAY
    K942177 FOLEY CATHETERIZATION TRAY
    K925018 IV PREP KIT W/O DRESSING (NON-STERILE)
    Search all 36 clearances from Customed, Inc. →