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

    GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING

    K Number: K121485 · Decision Aug 21, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    113
    Registration Numbers
    113
    Same Product Code
    126
    Applicant Total
    3
    Review Days
    95

    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
    GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING
    K Number
    K121485
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hemcon Medical Technologies Europe, Ltd.
    Date Received
    May 18, 2012
    Decision Date
    August 21, 2012
    Product Code
    QSY
    Advisory Committee
    Unknown
    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
    QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

    Similar 510(k) Clearances

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

    BloodSTOP iX Trauma Matrix (TM-iX-20)

    FDA 510(k)
    FDA Unclassified ·Unknown

    Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cm

    FDA 510(k)
    FDA Unclassified ·Unknown

    MFUSE (MS001)

    FDA 510(k)
    FDA Unclassified ·Unknown

    TRAUMAGEL® 2.0 Hemostatic Gel

    FDA 510(k)
    FDA Unclassified ·Unknown

    TRAUMAGEL®

    FDA 510(k)
    FDA Unclassified ·Unknown

    Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Hemcon Medical Technologies Europe, Ltd.

    K Number Device Name
    K112215 HEMCON HEMOSTATIC GEL
    K093729 GUARDIVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 IN/ 4MM, STERILE, GUARD IVA ANTIMICROBIAL HAEMOSTATIC IV DRESSING, 1 I