BEUDAMED
    Product Code: KGW FDA class 2 21 CFR 878.4370

    Ring (Wound Protector), Drape Retention, Internal

    General, Plastic Surgery

    Internal Drape Retention Ring (Wound Protector) is a device placed within a surgical wound opening to hold draping material in position and protect the wound edges from contamination, reducing the risk of surgical site infection by maintaining a clean barrier between the incision edges and the external environment. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KGW, regulated under 21 CFR 878.4370, within the General, Plastic Surgery medical specialty.

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    510(k)s
    9
    FEI Numbers
    29
    Registration Numbers
    29
    Unique Applicants
    5
    Years Active
    47

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    Basic Information

    Product Code
    KGW
    Device Class
    FDA class 2
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 9 510(k) clearances via K numbers.

    K Number Device Name
    K260982 Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)
    K253531 Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)
    K113268 ALEXIS O WOUND PROTECTOR/RETRACTOR
    K100120 ALEXIS ORTHOPAEDIC WOUND RETRACTOR
    K093296 ALEXIS LAPAROSCOPIC SYSTEM
    K062907 ALEXIS WOUND RETRACTOR
    K041711 ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304
    K840946 MICROPOROUS HYPOALLERGENIC
    K790306 EDGE PROTECTOR, BARRIER

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.