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

    COLOSHIELD COLONOSCOPY DRAPE MODEL E2000

    K Number: K020581 · Decision Sep 18, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    449
    Applicant Total
    6
    Review Days
    209

    Basic Information

    Device Name
    COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
    K Number
    K020581
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDICAL CONCEPTS DEVELOPMENT, INC.
    Date Received
    February 21, 2002
    Decision Date
    September 18, 2002
    Product Code
    KKX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KKX Drape, Surgical

    Similar 510(k) Clearances

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

    BeneHold™ Surgical Incise Drape with CHG antimicrobial II

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    BeneHold Surgical Incise Drape with CHG antimicrobial

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ControlRad Sterile Cover

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MediClear PreOp

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Plus Surgical Drapes (EO Sterilized), PMDB-XXX

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by MEDICAL CONCEPTS DEVELOPMENT, INC.

    K Number Device Name
    K000442 ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6650,D6651, D66XX
    K924794 TRANSPARENT ADHESIVE DRESSING
    K870044 MCD SPECIALTY BRAND NEEDLE COUNTERS
    K861530 SURGICAL PACKS, KITS AND TRAYS
    K861531 DISPOSABLE SURGICAL DRAPES AND ACCESSORIES