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

    ABSORBENT ANTIMICROBIAL WOUND DRESSING

    K Number: K013814 · Decision Jun 21, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    81
    Review Days
    217

    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
    ABSORBENT ANTIMICROBIAL WOUND DRESSING
    K Number
    K013814
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Convatec, A Division of E.R. Squibb & Sons
    Date Received
    November 16, 2001
    Decision Date
    June 21, 2002
    Product Code
    FRO
    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
    FRO Dressing, Wound, Drug

    Similar 510(k) Clearances

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

    Bonvadis®

    FDA 510(k)
    FDA Unclassified ·Unknown

    StatSeal Disc

    FDA 510(k)
    FDA Unclassified ·Unknown

    IWD-Gel™

    FDA 510(k)
    FDA Unclassified ·Unknown

    MiraChlor Antimicrobial Wound Solution

    FDA 510(k)
    FDA Unclassified ·Unknown

    Promogran Prisma™ Collagen Matrix with ORC and Silver

    FDA 510(k)
    FDA Unclassified ·Unknown

    LUOFUCON® Antimicrobial Wound Gel

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Convatec, A Division of E.R. Squibb & Sons

    K Number Device Name
    K990964 SIGNADRESS DUODERM DRESSING
    K984388 HA ABSORBENT WOUND DRESSING
    K980720 NONWOVEN PAD
    K980382 NON-WOVEN COMPRESS
    K974823 NONWOVEN DRESSING
    K974205 KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
    K974304 GERMICIDAL CLOTH
    K973632 DUODERM CGF CONTROL GEL FORMULA DRESSING
    K972530 CONVATEC ODOR CONTROL WOUND DRESSING
    K972062 CONVATEC NON-ADHESIVE DRESSING
    Search all 81 clearances from Convatec, A Division of E.R. Squibb & Sons →