FDA 510(k) Applications for Medical Device Product Code "ESW"
(Prosthesis, Esophageal)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K060239 | ALVEOLUS, INC. | ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM | 03/22/2006 |
| K080838 | ALVEOLUS, INC. | ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | 04/24/2008 |
| K051621 | ALVEOLUS, INC. | ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | 07/11/2005 |
| K233939 | Boston Scientific | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | 04/29/2024 |
| K955347 | BOSTON SCIENTIFIC CORP. | ULTRAFLEX | 02/16/1996 |
| K032930 | BOSTON SCIENTIFIC CORP. | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | 10/23/2003 |
| K012883 | BOSTON SCIENTIFIC CORP. | ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM | 10/12/2001 |
| K073266 | BOSTON SCIENTIFIC CORP. | WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM | 02/27/2008 |
| K211960 | Boston Scientific Corporation | Agile Esophageal OTW Stent System | 11/22/2021 |
| K180144 | Boston Scientific Corporation | Agile Esophageal Stent System | 09/21/2018 |
| K233837 | Boston Scientific Corporation | Agile Esophageal Stent System | 04/04/2024 |
| K080332 | Boston Scientific Corporation | POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 | 09/05/2008 |
| K091816 | Boston Scientific Corporation | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | 07/01/2009 |
| K120983 | Boston Scientific Corporation | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | 05/02/2012 |
| K130004 | Boston Scientific Corporation | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | 12/06/2013 |
| K091510 | Boston Scientific Corporation | WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 | 06/26/2009 |
| K002094 | C.R. BARD, INC. | BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE | 10/06/2000 |
| K093619 | COOK IRELAND LTD | EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E | 06/17/2010 |
| K080359 | COOK IRELAND LTD | EVOLUTION ESOPHAGEAL STENT SYSTEM | 05/09/2008 |
| K162717 | Cook Ireland Ltd. | Evolution Esophageal Stent System û Partially Covered | 12/21/2016 |
| K092144 | ENDOCHOICE, INC. | BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR | 02/22/2010 |
| K955041 | INSTENT, INC. | INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM | 02/21/1996 |
| K201160 | M.I. Tech Co., Ltd | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | 07/23/2021 |
| K200860 | M.I. Tech Co., Ltd | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | 05/20/2020 |
| K072094 | M.I. TECH CO., LTD. | CHOOSTENT | 09/25/2008 |
| K093537 | M.I. TECH CO., LTD. | HANAROSTENT ESOPHAGUS (CCC) | 06/04/2010 |
| K213251 | M.I.Tech Co., Ltd. | HANAROSTENT Esophagus Asymmetric (CCC) | 11/18/2021 |
| K973584 | MEDTECH INSTRUMENTS | MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM | 01/09/1998 |
| K983297 | MEDTRONIC INSTENT, INC. | MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE | 12/18/1998 |
| K111611 | MERIT MEDICAL SYSTEMS, INC. | ENDOMAXX FULLY COVERED ESOPHAGEAL STENT | 07/29/2011 |
| K251265 | Merit Medical Systems, Inc. | Resilience Fully Covered Esophageal Stent System | 07/23/2025 |
| K182910 | Micro-Tech (Nanjing) Co., Ltd. | Segmented Esophageal Stent System | 05/29/2019 |
| K172813 | Micro-Tech (Nanjing) Co.,Ltd. | Esophageal Stent System | 05/18/2018 |
| K030559 | RUSCH INTL. | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM | 06/30/2003 |
| K010068 | RUSCH INTL. | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM | 02/08/2001 |
| K984068 | SCHNEIDER (EUROPE) GMBH | FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS | 01/07/1999 |
| K240522 | Taewoong Medical | Esophageal TTS Stent | 03/22/2024 |
| K123205 | TAEWOONG MEDICAL CO., LTD | ESOPHAGEAL TTS STENT | 10/09/2013 |
| K211706 | Taewoong Medical Co., Ltd | Esophageal TTS Stent | 10/08/2021 |
| K113551 | TAEWOONG MEDICAL CO., LTD | ESOPHAGEAL TTS STENT | 02/14/2012 |
| K080782 | TAEWOONG MEDICAL CO., LTD | NITI-S ESOPHAGEAL STENT | 01/30/2009 |
| K041648 | TAEWOONG MEDICAL CO., LTD | NITI-S STENT & INTRODUCER, MODEL EOXXXX | 04/28/2005 |
| K221482 | Taewoong Medical Co., Ltd. | Esophageal TTS Stent | 06/22/2022 |
| K223266 | Thoracent, Inc. | Hilzo Esophageal Stents | 01/16/2024 |
| K003173 | VASCULAR ARCHITECTS, INC. | ASPIRE COVERED STENT AND DELIVERY CATHETER | 03/13/2001 |
| K011591 | WILSON-COOK MEDICAL, INC. | ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE | 07/19/2002 |
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