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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    Nexo-Gide Bilayer Collagen Membrane

    K Number: K203496 · Decision Jul 14, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    89
    Registration Numbers
    89
    Same Product Code
    162
    Applicant Total
    27
    Review Days
    229

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    Basic Information

    Device Name
    Nexo-Gide Bilayer Collagen Membrane
    K Number
    K203496
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Geistlich Pharma AG
    Date Received
    November 27, 2020
    Decision Date
    July 14, 2021
    Product Code
    FTM
    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
    FTM Mesh, Surgical

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    Other Clearances by Geistlich Pharma AG

    K Number Device Name
    K260364 Device 300419 Strip
    K260532 Derma-Gide
    K251323 Device 104 Particulate
    K252253 Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®
    K251062 Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi Pack
    K251556 Device 300423 Granules
    K251786 Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®
    K251613 SwissGraft X
    K250833 SwissMembrane X; SwissMembrane X Socket
    K242510 Geistlich Bio-Flow®
    Search all 27 clearances from Geistlich Pharma AG →