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

    EDGE PROTECTOR, BARRIER

    K Number: K790306 · Decision Feb 22, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    8
    Applicant Total
    56
    Review Days
    9

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    Basic Information

    Device Name
    EDGE PROTECTOR, BARRIER
    K Number
    K790306
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgikos, Inc.
    Date Received
    February 13, 1979
    Decision Date
    February 22, 1979
    Product Code
    KGW
    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
    KGW Ring (Wound Protector), Drape Retention, Internal

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    Other Clearances by Surgikos, Inc.

    K Number Device Name
    K875107 HEALTH CARE EYE PROTECTION
    K874653 STERILE SURGICAL SCRUB BRUSH
    K861441 NEUTRALON SURGICAL GLOVES
    K852870 BARRIER SURGICAL GOWN
    K822535 CIDEX*DIALYZER DISINFECTING SOLUTION
    K820543 BARRIER ANTIMICROBIAL INCISE DRAPE
    K820542 SURGIKOS INCISE DRAPE
    K811871 BACTERICIDAL INCISE DRAPE
    K810316 SURGIKOS FACE MASK
    K801864 BARRIER APERTURED DRAPE
    Search all 56 clearances from Surgikos, Inc. →