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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: FGE FDA class 2

    Stents, Drains And Dilators For The Biliary Ducts

    Gastroenterology, Urology

    View full classification →

    Biliary Duct Stents, Drains, and Dilators are devices used to maintain patency, provide drainage, or dilate strictures within the biliary ductal system, typically in the treatment of biliary obstruction from benign or malignant causes. They are classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is FGE, regulated under 21 CFR 876.5010, within the Gastroenterology, Urology specialty. This device is both an implant and is considered life-sustaining or life-supporting.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Dilation Balloon Catheter
    Endoflux™ Biliary & Pancreatic Stent Sets
    BARE Wireguided Balloon Dilation Catheter (1235)
    Single use stone retrieval balloons
    Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
    BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
    Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
    EndoFix™Tissue Fixation System
    ARCHIMEDES Biodegradable Pancreatic Stent
    Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
    EGIS Biliary Double Bare Stent (BDB080405)
    Single-use Balloon Dilatation Catheter
    Tornus ES
    WallFlex Biliary PLUS RX Stent System
    WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
    Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)
    VedDilator ^TM (3-Stage Balloon Dilation Catheter)
    EndoGI S-Path Biliary Stent System
    EGIS Biliary Single Bare Stent
    Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
    WallFlex™ Biliary RX Stent System
    Niti-S Biliary Speed D Stent
    MultiStage Balloon Dilatation Catheter
    Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
    EndoGI S-Path Biliary Stent System
    Niti-S Biliary Slim M Stent
    Compass BDS Biliary Stent
    Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
    BIOTEQ Drainage Catheter BT-PDS-series
    HANAROSTENT Benefit Biliary (NNN)
    Advanix Biliary Stent with NaviFlex RX Delivery System
    BIOTEQ Drainage Catheter Set (One Step Type)
    EndoGI S-Path Biliary Stent System
    EndoGI Biliary Stent System
    ConvertX Biliary Stent System
    HANAROSTENT FASTTM Biliary (NNN)
    Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
    Reliant(TM) Multistage Dilatation Balloon Catheter
    Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
    Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
    Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
    Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
    Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S
    Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
    CRE RX Biliary Balloon Dilatation Catheter
    Epic Biliary Endoscopic Stent System
    Nasal Pancreatic Drainage Set
    Quantum TTC Biliary Balloon Dilator
    GORE VIABIL Short Wire Biliary Endoprosthesis
    AngioDynamics Total Abscession Biliary Drainage Catheter

    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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