BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DEXON VIOLET

    K Number: K972566 · Decision Aug 14, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    140
    Registration Numbers
    140
    Same Product Code
    147
    Applicant Total
    45
    Review Days
    36

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    Basic Information

    Device Name
    DEXON VIOLET
    K Number
    K972566
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4493
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Davis & Geck, Inc.
    Date Received
    July 9, 1997
    Decision Date
    August 14, 1997
    Product Code
    GAM
    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
    GAM Suture, Absorbable, Synthetic, Polyglycolic Acid

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    Other Clearances by Davis & Geck, Inc.

    K Number Device Name
    K982853 SILK SUTURE
    K981582 SURGILON, DERMALON, & OPHTHALON
    K980610 DEXON RAPID (DEXON R)
    K974015 ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL CATHETER- PICC TRAYS, ARGYLE QUICK- PICC PERIPHERALLY INSERTED CENTRAL
    K980062 MONOJECTT BLUNTIP I.V. ACCESS CANNULA WITH VIAL ACCESS PIN DEVICE
    K973409 KANGAROO ENTERAL FEEDING EXTENSION SET FOR SYRINGE PUMPS
    K970857 ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL ARGYLE AQUA-SEAL EVACUATING AUTOTRANSFUSIO
    K972139 ASPR-CARE CLOSED SYSTEM,DUAL SWIVEL PIECE T,SHEATHED SUCTION CATHETER,BRONCHOSOPE ADAPTER,IN-LINE SPECIMEN TRAP
    K962971 POLYPROPYLENE MESH (VARIOUS SIZES)
    K955722 FLEXON TEMPORARY CARDIAC PACER LEAD
    Search all 45 clearances from Davis & Geck, Inc. →