BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY

    K Number: K844625 · Decision Jan 16, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    21
    Applicant Total
    10
    Review Days
    50

    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
    BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY
    K Number
    K844625
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4018
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Bipore, Inc.
    Date Received
    November 27, 1984
    Decision Date
    January 16, 1985
    Product Code
    KOZ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KOZ Beads, Hydrophilic, For Wound Exudate Absorption

    Similar 510(k) Clearances

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

    INCARE PINSITE DRESSING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    CUTINOVA HYDRO

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    IODOSORB GEL

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    REDI-RELEASE ABSORBENT DRESSING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BIOCLUSIVE(R) ABSORBENT DRESSING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    DERMASORB WOUND CONTACT LAYER DRESSING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Bipore, Inc.

    K Number Device Name
    K073434 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
    K073318 BIPORE BALLOON DILATION CATHETER
    K051513 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
    K041293 BIOPORE BALLOON DILATION CATHETER
    K983650 BIPORE BALLOON DILATATION CATHETER
    K973563 BIPORE BALLOON DILATATION CATHETER
    K964814 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER
    K961980 BIPORE BALLOON DILATATION CATHETER
    K862015 O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER