BEUDAMED
    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: GAT FDA class 2

    Suture, Nonabsorbable, Synthetic, Polyethylene

    General, Plastic Surgery

    View full classification →

    The Suture, Nonabsorbable, Synthetic, Polyethylene (product code GAT) is a synthetic, nonabsorbable suture constructed from polyethylene, used in general and plastic surgery to provide lasting wound closure and tissue approximation where permanent suture material is indicated. It is classified as FDA Class 2, requiring a 510(k) premarket notification to demonstrate substantial equivalence. The device is regulated under 21 CFR 878.5000 in the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is placed through body tissue during application.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™
    HyperSuture All Green Extension Line
    Meniscus Versaflex
    Pre-Sutured Tendon
    ProZip Knotless Implant
    PowerKnot High Strength Sutures
    HS Fiber
    HyperSuture White/Green Extension Line
    HyperSuture All Blue Extension Line
    HyperSuture Extension Line
    HS Fiber Sutures
    HyperSuture
    Non absorbable Surgical Polyester Suture
    SuperBall Meniscal Repair System
    MENIX®; MENIX® DUO
    MyEllevate
    AceConnex Pre-Sutured Fascia
    Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
    ACTIVBRAID™
    Arthrex BioSuture
    Arthrex SoftStitch
    Arthrex SutureTape
    Zone Specific AIM
    PERMALOOP Suture, PERMATAPE Suture
    Arthrex LoopLoc Knotless Suture
    EasyWhip
    DYNATAPE Suture
    FAST-FIX FLEX
    Arthrex SoftStitch
    HS Fiber
    Arthrex SutureTape
    Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch
    High Strength Suture
    DemeTECH DemeFORCE Nonabsorbable Surgical Suture
    Force Fiber Suture
    HS Fiber
    MTF Pre-Sutured Tendon
    Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures; Force Fiber OrthoTape suture; Bondek suture and Bondek Plus suture; Monodek suture; Polyglytone*6211 suture
    DYNACORD Suture
    NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0)
    SuperBall Meniscal Repair System
    NovoStitch Pro Meniscal Repair System
    ReConnex Pre-Sutured Tendon
    Force Fiber Fusion Suture
    GRAVITY™ Soft Tissue Repair System
    Infinity-Lock 3, Infinity-Lock 5
    SutureTape
    ExpressBraid Graft Manipulation
    SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; SpeedStitch Needle Loader and Unloader
    MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump