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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: FTM FDA class 2

    Mesh, Surgical

    General, Plastic Surgery

    View full classification →

    A surgical mesh is a woven or knitted implantable material used to provide structural support during tissue repair or reconstruction procedures, including hernia and pelvic floor repair. 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 FTM, 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
    Endoform Reconstructive Template - PLGA
    OviTex PRS (Long-Term Resorbable)
    CanGaroo RM Antibacterial Envelope
    OviTex PRS
    Peri-Guard and Supple Peri-Guard
    OviTex PRS (Long Term Resorbable)
    VersaWrap
    PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology
    Nexo-Gide Bilayer Collagen Membrane
    VersaWrap
    Lyograft
    Biodesign Staple Line Reinforcement
    CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ)
    VersaWrap Tendon Protector
    Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG)
    CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ)
    Bovine Pericardial Tissue Patch
    Endoform Restella
    DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional
    Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
    CanGaroo Neuro Envelope (small) ; CanGaroo Neuro Envelope (medium) ; CanGaroo Neuro Envelope (large) ; CanGaroo Neuro Envelope (extra large)
    Biodesign Diaphragmatic Hernia Graft
    Colorado Therapeutics Xenograft Implant
    CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)
    Biodesign Parastomal Hernia Repair Graft
    Biodesign Fistula Plug
    Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend
    ARTIA Reconstructive Tissue Matrix Perforated
    Miromatrix Biological Mesh TW
    SurgiMend MP Collagen Matrix for Soft Tissue Reconstruction
    CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)
    Endoform Plastics and Reconstructive Matrix
    Gentrix Surgical Matrix
    COLORADO THERAPEUTICS XENOGRAFT IMPLANT
    Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug
    Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft
    Endoform Reconstructive Template
    SurgiPure XD Reconstructive Tissue Matrix
    Biodesign Enterocutaneous Fistula Plug
    SIS Inguinal Hernia Repair Graft
    LTM-Perforated Surgical Mesh
    Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
    HP Tissue Matrix
    BOVINE PERICARDIUM PATCH
    OVINE TISSUE MATRIX(OTM)
    FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
    CORMATRIX PROTECT ECM ENVELOPE
    SIS HERNIA GRAFT
    XENMATRIX SURGICAL GRAFT
    MIROMATRIX BIOLOGICAL MESH

    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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