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

    AMERICAN PHARMASEAL WOUND DRESSING

    K Number: K871770 · Decision Jun 26, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    64
    Review Days
    51

    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
    AMERICAN PHARMASEAL WOUND DRESSING
    K Number
    K871770
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    American Pharmaseal Div. Ahsc
    Date Received
    May 6, 1987
    Decision Date
    June 26, 1987
    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 American Pharmaseal Div. Ahsc

    K Number Device Name
    K874022 PHARMASEAL WOUND IRRIGATION DEVICE
    K874517 PHARMASEAL RUBBER URETHRAL CATHETER
    K874045 PHARMASEAL ENDOSCOPY PREP KIT UPPER AND LOWER
    K873359 AIRLIFE VOLUME VENTI. CIRCUIT W/CLEAR CAP EX VALVE
    K872228 PHARMASEAL ALTERNATING PRESSURE PAD SYSTEM
    K872917 JINOTTI SUCTION/OXYGEN INSUFFLATION CATHETER
    K871429 ANTIMICROBIAL FOLEY CATHETER
    K870387 EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE
    K870977 PHARMASEAL T TYPE THERMOCOUPLE 100% CATH./PROBE
    K870941 PHARMASEAL WOUND CARE DRESSING PAD
    Search all 64 clearances from American Pharmaseal Div. Ahsc →