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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: FTL FDA class 2

    Mesh, Surgical, Polymeric

    General, Plastic Surgery

    View full classification →

    A polymeric surgical mesh is a synthetic, porous material implanted surgically to reinforce or reconstruct weakened or damaged tissue, commonly used in hernia repair and other reconstructive procedures. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FTL, regulated under 21 CFR 878.3300, within the General, Plastic Surgery medical specialty. This device is designated as an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Bard® Mesh; Bard® Mesh Pre-Shaped
    Parietene™ Macroporous Mesh (PPM5050 )
    Bard Soft Mesh; Bard Soft Mesh Pre-Shaped
    ProGrip™ Self-Gripping Polypropylene Mesh
    3DMax Light Mesh
    Progrip™ Self-Gripping Polypropylene Mesh
    Bard 3DMax Mesh
    T-Line® Hernia Mesh
    Pitch PaSoft Tissue Reinforcement Device
    T-Line Hernia Mesh
    Parietene Macroporous Mesh
    T-Line Hernia Mesh
    ProGrip Self-Gripping Polypropylene Mesh
    Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
    Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh
    ARISTE AB Mesh
    Pitch-Patchs
    SurgiWrap FROST
    VICRYL Mesh
    3DMax MID Anatomical Mesh
    TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
    T-Line Hernia Mesh
    TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
    Dextile Anatomical Mesh
    VICRYL Mesh
    FlexBand Plus
    Exogenesis Hernia Mesh
    Phasix ST Mesh with Echo 2 Positioning System
    Endoform Reconstructive Template - Non Absorbable
    DynaMesh-POSTERIOR
    Polydioxanone Surgical Scaffold
    PROLENE (Polypropylene) 3D Patch
    ULTRAPRO Mesh and ULTRAPRO ADVANCED
    PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh
    TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
    VitaMESH Macroporous PP Surgical Mesh
    TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
    Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
    Duatene bilayer mesh
    PROLENE Soft Polypropylene Mesh
    Reperen Surgical Mesh
    Parietene DS Composite Mesh
    GORE SYNECOR Preperitoneal Biomaterial
    VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 25cm (6”x10”) Oval
    PROLENE Soft Polypropylene Mesh
    DynaMesh-VENTRAL
    Endoform Reconstructive Template
    Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay
    GORE SYNECOR Biomaterial
    TYRX Neuro Antibacterial Envelope

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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