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

    STIMULEN COLLAGEN

    K Number: K030774 · Decision Aug 9, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    134
    Registration Numbers
    134
    Same Product Code
    187
    Applicant Total
    5
    Review Days
    517

    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
    STIMULEN COLLAGEN
    K Number
    K030774
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Southwest Technologies, Inc.
    Date Received
    March 11, 2003
    Decision Date
    August 9, 2004
    Product Code
    KGN
    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
    KGN Wound Dressing With Animal-Derived Material(S)

    Similar 510(k) Clearances

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

    ECMT-100 WMD

    FDA 510(k)
    FDA Unclassified ·Unknown

    Catalyze

    FDA 510(k)
    FDA Unclassified ·Unknown

    Roosin Collagen Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    Roosin Collagen Powder

    FDA 510(k)
    FDA Unclassified ·Unknown

    MatriDerm

    FDA 510(k)
    FDA Unclassified ·Unknown

    Derma-Gide

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Southwest Technologies, Inc.

    K Number Device Name
    K102478 OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING
    K083334 ELASTO-GEL MANUKA HONEY WOUND DRESSING
    K872488 ELASTO-GEL CAST & SPLINT PADS
    K872165 ELASTO-GEL OCCLUSIVE DRESSING