BEUDAMED
    Product Code: OXC FDA class 2 21 CFR 878.3300

    Mesh, Surgical, Absorbable, Staple Line Reinforcement

    General, Plastic Surgery

    The Mesh, Surgical, Absorbable, Staple Line Reinforcement is an absorbable surgical mesh implant used for reinforcement of soft tissue where weakness exists during staple line reinforcement procedures such as bariatric or gastrointestinal surgery. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OXC, with regulation number 878.3300 under the General, Plastic Surgery medical specialty, and it carries an implant flag.

    View on FDA
    510(k)s
    9
    FEI Numbers
    21
    Registration Numbers
    21
    Unique Applicants
    4
    Years Active
    12

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    Basic Information

    Product Code
    OXC
    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 staple line reinforcement procedures.

    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
    K252906 ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)
    K231603 Standard Staple-Line Reinforcement (SSLR23)
    K221343 ECHELON ENDOPATH Staple Line Reinforcement
    K221487 NEOVEIL Staple Line Reinforcement
    K190937 Echelon Endopath Staple Line Reinforcement
    K181940 GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement
    K150551 GORE SEAMGUARD Reinforcement
    K130997 NEOVEIL
    K131658 GORE SEAMGUARD REINFORCEMENT

    FEI Numbers

    This FDA classification entry is associated with 21 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 21 registration numbers. Click on an entry to view related FDA registrations.