BEUDAMED
    Product Code: OWV FDA class 2 21 CFR 878.3300

    Mesh, Surgical, Collagen, Diaphragmatic Hernia

    General, Plastic Surgery

    The Mesh, Surgical, Collagen, Diaphragmatic Hernia is a collagen-based surgical mesh implant used for reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWV, with regulation number 878.3300 under the General, Plastic Surgery medical specialty, and it carries an implant flag.

    View on FDA
    510(k)s
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    OWV
    Device Class
    FDA class 2
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

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

    Definition

    For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K133011 DIAPHRAGMATIC HERNIA GRAFT

    FEI Numbers

    This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.