Panels › General, Plastic Surgery › Product code ESW · Class 2
Prosthesis, Esophageal
Regulation 878.3610
1510(k)s in 12 months (60 all time)
0recalls in 12 months (67 all time)
67recalls that name a 510(k)
Top companies in ESW
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific | 15 | 65 |
| Taewoong Medical | 8 | 1 |
| M.I.Tech Co., Ltd. | 6 | 0 |
| Wilson-Cook Medical, Inc. | 3 | 1 |
| Alveolus, Inc. | 3 | 0 |
| Cook Ireland, Ltd. | 3 | 0 |
| Boston Scientific Scimed, Inc. | 2 | 0 |
| Cook, Inc. | 2 | 0 |
| Hood Laboratories | 2 | 0 |
| Instent, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 2026 | K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System Boston Scientific Corporation | ESW |
| Oct 30, 2025 | K253327 | HANAROSTENT Esophagus Upper (CCC) M.I.Tech Co., Ltd., KR | ESW |
| Oct 30, 2025 | K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent Taewoong Medical Co., Ltd., KR | ESW |
| Jul 23, 2025 | K251265 | Resilience Fully Covered Esophageal Stent System Merit Medical Systems, Inc. | ESW |
| Apr 29, 2024 | K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System Boston Scientific | ESW |
| Apr 4, 2024 | K233837 | Agile Esophageal Stent System Boston Scientific Corporation | ESW |
| Mar 22, 2024 | K240522 | Esophageal TTS Stent Taewoong Medical, KR | ESW |
| Jan 16, 2024 | K223266 | Hilzo Esophageal Stents Thoracent, Inc. | ESW |
| Jun 22, 2022 | K221482 | Esophageal TTS Stent Taewoong Medical Co., Ltd., KR | ESW |
| Nov 22, 2021 | K211960 | Agile Esophageal OTW Stent System Boston Scientific Corporation | ESW |
| Nov 18, 2021 | K213251 | HANAROSTENT Esophagus Asymmetric (CCC) M.I.Tech Co., Ltd., KR | ESW |
| Oct 8, 2021 | K211706 | Esophageal TTS Stent Taewoong Medical Co., Ltd., KR | ESW |
| Jul 23, 2021 | K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) M.I.Tech Co., Ltd., KR | ESW |
| May 20, 2020 | K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) M.I.Tech Co., Ltd., KR | ESW |
| May 29, 2019 | K182910 | Segmented Esophageal Stent System Micro-Tech (Nanjing) Co., Ltd., CN | ESW |
| Sep 21, 2018 | K180144 | Agile Esophageal Stent System Boston Scientific Corporation | ESW |
| May 18, 2018 | K172813 | Esophageal Stent System Micro-Tech (Nanjing) Co., Ltd., CN | ESW |
| Dec 21, 2016 | K162717 | Evolution Esophageal Stent System Partially Covered Cook Ireland, Ltd., IE | ESW |
| Dec 6, 2013 | K130004 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation | ESW |
| Oct 9, 2013 | K123205 | ESOPHAGEAL TTS STENT Taewoong Medical Co., Ltd. | ESW |
| May 2, 2012 | K120983 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation | ESW |
| Feb 14, 2012 | K113551 | ESOPHAGEAL TTS STENT Taewoong Medical Co., Ltd. | ESW |
| Jul 29, 2011 | K111611 | ENDOMAXX FULLY COVERED ESOPHAGEAL STENT Merit Medical Systems, Inc. | ESW |
| Jun 17, 2010 | 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 Cook Ireland, Ltd., IE | ESW |
| Jun 4, 2010 | K093537 | HANAROSTENT ESOPHAGUS (CCC) M.I.Tech Co., Ltd. | ESW |
| Feb 22, 2010 | K092144 | BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR Endochoice, Inc. | ESW |
| Jul 1, 2009 | K091816 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corporation | ESW |
| Jun 26, 2009 | K091510 | WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 Boston Scientific Corporation | ESW |
| Jan 30, 2009 | K080782 | NITI-S ESOPHAGEAL STENT Taewoong Medical Co., Ltd. | ESW |
| Sep 25, 2008 | K072094 | CHOOSTENT M.I.Tech Co., Ltd. | ESW |
| Sep 5, 2008 | K080332 | POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 Boston Scientific Corporation | ESW |
| May 9, 2008 | K080359 | EVOLUTION ESOPHAGEAL STENT SYSTEM Cook Ireland, Ltd., IE | ESW |
| Apr 24, 2008 | K080838 | ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM Alveolus, Inc. | ESW |
| Feb 27, 2008 | K073266 | WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM Boston Scientific Corp | ESW |
| Mar 22, 2006 | K060239 | ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM Alveolus, Inc. | ESW |
| Jul 11, 2005 | K051621 | ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM Alveolus, Inc. | ESW |
| Apr 28, 2005 | K041648 | NITI-S STENT & INTRODUCER, MODEL EOXXXX Taewoong Medical Co., Ltd. | ESW |
| Oct 23, 2003 | K032930 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM Boston Scientific Corp | ESW |
| Jun 30, 2003 | K030559 | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM Rusch Intl. | ESW |
| Jul 19, 2002 | K011591 | ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE Wilson-Cook Medical, Inc. | ESW |
| Oct 12, 2001 | K012883 | ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM Boston Scientific Corp | ESW |
| Mar 13, 2001 | K003173 | ASPIRE COVERED STENT AND DELIVERY CATHETER Vascular Architects, Inc. | ESW |
| Feb 8, 2001 | K010068 | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM Rusch Intl. | ESW |
| Oct 6, 2000 | K002094 | BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE C.R. Bard, Inc. | ESW |
| Jan 7, 1999 | K984068 | FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS Schneider (Europe) GmbH, SE | ESW |
| Dec 18, 1998 | K983297 | MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE Medtronic Instent, Inc. | ESW |
| Jan 9, 1998 | K973584 | MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM Medtech Instruments | ESW |
| Feb 21, 1996 | K955041 | INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM Instent, Inc. | ESW |
| Feb 16, 1996 | K955347 | ULTRAFLEX Boston Scientific Corp | ESW |
| Feb 23, 1995 | K941487 | INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS Instent, Inc. | ESW |
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