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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: ESW FDA class 2

    Prosthesis, Esophageal

    General, Plastic Surgery

    View full classification →

    The esophageal prosthesis is an implantable device designed to maintain patency of the esophagus in patients with conditions such as esophageal stricture, malignancy, or tracheoesophageal fistula. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and carries an implant designation reflecting its placement within the body. The product code is ESW, regulated under 21 CFR 878.3610 in the General, Plastic Surgery specialty. This device is designated as an implant.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
    Agile Esophageal Stent System
    Esophageal TTS Stent
    Hilzo Esophageal Stents
    Esophageal TTS Stent
    Agile Esophageal OTW Stent System
    HANAROSTENT Esophagus Asymmetric (CCC)
    Esophageal TTS Stent
    HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
    HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
    Segmented Esophageal Stent System
    Agile Esophageal Stent System
    Esophageal Stent System
    Evolution Esophageal Stent System – Partially Covered
    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
    ESOPHAGEAL TTS STENT
    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
    ESOPHAGEAL TTS STENT
    ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
    EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
    HANAROSTENT ESOPHAGUS (CCC)
    BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
    WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730
    NITI-S ESOPHAGEAL STENT
    CHOOSTENT
    POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
    EVOLUTION ESOPHAGEAL STENT SYSTEM
    ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
    WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
    ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
    ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
    NITI-S STENT & INTRODUCER, MODEL EOXXXX
    ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
    RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
    ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
    ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
    ASPIRE COVERED STENT AND DELIVERY CATHETER
    RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
    BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
    FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS
    MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE
    MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM
    INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM
    ULTRAFLEX
    INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS
    COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
    WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)
    WALLSTENT ESOPHAGEAL PROSTHESIS
    MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM

    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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