BEUDAMED
    Product Code: ESW FDA class 2 21 CFR 878.3610

    Prosthesis, Esophageal

    General, Plastic Surgery

    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.

    View on FDA
    510(k)s
    59
    FEI Numbers
    31
    Registration Numbers
    31
    Unique Applicants
    24
    Years Active
    39

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    Basic Information

    Product Code
    ESW
    Device Class
    FDA class 2
    Regulation Number
    878.3610
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 59 510(k) clearances via K numbers.

    K Number Device Name
    K253327 HANAROSTENT Esophagus Upper (CCC)
    K243619 Niti-S Esophageal Stent; Esophageal TTS Stent
    K251265 Resilience Fully Covered Esophageal Stent System
    K233939 Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
    K233837 Agile Esophageal Stent System
    K240522 Esophageal TTS Stent
    K223266 Hilzo Esophageal Stents
    K221482 Esophageal TTS Stent
    K211960 Agile Esophageal OTW Stent System
    K213251 HANAROSTENT Esophagus Asymmetric (CCC)
    K211706 Esophageal TTS Stent
    K201160 HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)
    K200860 HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)
    K182910 Segmented Esophageal Stent System
    K180144 Agile Esophageal Stent System
    K172813 Esophageal Stent System
    K162717 Evolution Esophageal Stent System – Partially Covered
    K130004 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
    K123205 ESOPHAGEAL TTS STENT
    K120983 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
    K113551 ESOPHAGEAL TTS STENT
    K111611 ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
    K093619 EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E
    K093537 HANAROSTENT ESOPHAGUS (CCC)
    K092144 BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR
    K091816 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
    K091510 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730
    K080782 NITI-S ESOPHAGEAL STENT
    K072094 CHOOSTENT
    K080332 POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
    K080359 EVOLUTION ESOPHAGEAL STENT SYSTEM
    K080838 ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
    K073266 WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
    K060239 ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM
    K051621 ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM
    K041648 NITI-S STENT & INTRODUCER, MODEL EOXXXX
    K032930 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
    K030559 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
    K011591 ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
    K012883 ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
    K003173 ASPIRE COVERED STENT AND DELIVERY CATHETER
    K010068 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
    K002094 BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE
    K984068 FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS
    K983297 MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE
    K973584 MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM
    K955041 INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM
    K955347 ULTRAFLEX
    K941487 INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS
    K945201 COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT
    K940396 WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE)
    K940395 WALLSTENT ESOPHAGEAL PROSTHESIS
    K940838 MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM
    K920218 ESOPHAGEAL Z-STENT
    K923119 WALLSTENT ESOPHAGEAL PROTHESIS
    K914029 ESOPHAGEAL Z-STENT
    K904821 ELIACHAR MODIFIED ESOPHAGEAL STENT
    K885309 WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS
    K871244 HOOD ESOPHAGEAL PROSTHESIS

    FEI Numbers

    This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.