FDA Product Code
FDA Product Code ESW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.3610
510(k) Clearances — 60 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | Boston Scientific Corporation | 2026-07-10 | Special | PDF ↗ |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2025-10-30 | Traditional | PDF ↗ |
| K253327 | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | 2025-10-30 | Special | PDF ↗ |
| K251265 | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | 2025-07-23 | Traditional | PDF ↗ |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | 2024-04-29 | Traditional | PDF ↗ |
| K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | 2024-04-04 | Traditional | PDF ↗ |
| K240522 | Esophageal TTS Stent | Taewoong Medical | 2024-03-22 | Special | PDF ↗ |
| K223266 | Hilzo Esophageal Stents | Thoracent, Inc. | 2024-01-16 | Traditional | PDF ↗ |
| K221482 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2022-06-22 | Special | PDF ↗ |
| K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | 2021-11-22 | Traditional | PDF ↗ |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | 2021-11-18 | Special | PDF ↗ |
| K211706 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2021-10-08 | Traditional | PDF ↗ |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | 2021-07-23 | Traditional | PDF ↗ |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | M.I.Tech Co., Ltd. | 2020-05-20 | Traditional | PDF ↗ |
| K182910 | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2019-05-29 | Traditional | PDF ↗ |
| K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018-09-21 | Traditional | PDF ↗ |
| K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2018-05-18 | Traditional | PDF ↗ |
| K162717 | Evolution Esophageal Stent System Partially Covered | Cook Ireland, Ltd. | 2016-12-21 | Traditional | PDF ↗ |
| K130004 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2013-12-06 | Traditional | PDF ↗ |
| K123205 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2013-10-09 | Traditional | PDF ↗ |
| K120983 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2012-05-02 | Special | PDF ↗ |
| K113551 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2012-02-14 | Traditional | PDF ↗ |
| K111611 | ENDOMAXX FULLY COVERED ESOPHAGEAL STENT | Merit Medical Systems, Inc. | 2011-07-29 | Special | PDF ↗ |
| 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. | 2010-06-17 | Traditional | PDF ↗ |
| K093537 | HANAROSTENT ESOPHAGUS (CCC) | M.I.Tech Co., Ltd. | 2010-06-04 | Special | PDF ↗ |
| K092144 | BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR | Endochoice, Inc. | 2010-02-22 | Traditional | PDF ↗ |
| K091816 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2009-07-01 | Special | PDF ↗ |
| K091510 | WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 | Boston Scientific Corporation | 2009-06-26 | Special | PDF ↗ |
| K080782 | NITI-S ESOPHAGEAL STENT | Taewoong Medical Co., Ltd. | 2009-01-30 | Abbreviated | PDF ↗ |
| K072094 | CHOOSTENT | M.I.Tech Co., Ltd. | 2008-09-25 | Traditional | PDF ↗ |
| K080332 | POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 | Boston Scientific Corporation | 2008-09-05 | Traditional | PDF ↗ |
| K080359 | EVOLUTION ESOPHAGEAL STENT SYSTEM | Cook Ireland, Ltd. | 2008-05-09 | Traditional | PDF ↗ |
| K080838 | ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | Alveolus, Inc. | 2008-04-24 | Special | PDF ↗ |
| K073266 | WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM | Boston Scientific Corp | 2008-02-27 | Traditional | PDF ↗ |
| K060239 | ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM | Alveolus, Inc. | 2006-03-22 | Traditional | PDF ↗ |
| K051621 | ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | Alveolus, Inc. | 2005-07-11 | Traditional | PDF ↗ |
| K041648 | NITI-S STENT & INTRODUCER, MODEL EOXXXX | Taewoong Medical Co., Ltd. | 2005-04-28 | Traditional | PDF ↗ |
| K032930 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corp | 2003-10-23 | Special | PDF ↗ |
| K030559 | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM | Rusch Intl. | 2003-06-30 | Traditional | PDF ↗ |
| K011591 | ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE | Wilson-Cook Medical, Inc. | 2002-07-19 | Traditional | PDF ↗ |
| K012883 | ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM | Boston Scientific Corp | 2001-10-12 | Special | PDF ↗ |
| K003173 | ASPIRE COVERED STENT AND DELIVERY CATHETER | Vascular Architects, Inc. | 2001-03-13 | Traditional | PDF ↗ |
| K010068 | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM | Rusch Intl. | 2001-02-08 | Abbreviated | PDF ↗ |
| K002094 | BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE | C.R. Bard, Inc. | 2000-10-06 | Traditional | PDF ↗ |
| K984068 | FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS | Schneider (Europe) GmbH | 1999-01-07 | Traditional | PDF ↗ |
| K983297 | MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE | Medtronic Instent, Inc. | 1998-12-18 | Traditional | PDF ↗ |
| K973584 | MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM | Medtech Instruments | 1998-01-09 | Traditional | PDF ↗ |
| K955041 | INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM | Instent, Inc. | 1996-02-21 | Traditional | PDF ↗ |
| K955347 | ULTRAFLEX | Boston Scientific Corp | 1996-02-16 | Traditional | PDF ↗ |
| K941487 | INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS | Instent, Inc. | 1995-02-23 | Traditional | PDF ↗ |
| K945201 | COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT | Cook, Inc. | 1995-01-04 | Traditional | PDF ↗ |
| K940396 | WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) | Boston Scientific Scimed, Inc. | 1994-10-03 | Traditional | PDF ↗ |
| K940395 | WALLSTENT ESOPHAGEAL PROSTHESIS | Boston Scientific Scimed, Inc. | 1994-09-20 | Traditional | PDF ↗ |
| K940838 | MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM | Boston Scientific Corp | 1994-08-18 | Traditional | PDF ↗ |
| K920218 | ESOPHAGEAL Z-STENT | Wilson-Cook Medical, Inc. | 1994-02-09 | Traditional | PDF ↗ |
| K923119 | WALLSTENT ESOPHAGEAL PROTHESIS | Schneider U.S. Stent Div. | 1992-09-01 | Traditional | PDF ↗ |
| K914029 | ESOPHAGEAL Z-STENT | Cook, Inc. | 1991-12-09 | Traditional | PDF ↗ |
| K904821 | ELIACHAR MODIFIED ESOPHAGEAL STENT | Hood Laboratories | 1991-01-14 | Traditional | PDF ↗ |
| K885309 | WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS | Wilson-Cook Medical, Inc. | 1990-02-09 | Traditional | PDF ↗ |
| K871244 | HOOD ESOPHAGEAL PROSTHESIS | Hood Laboratories | 1987-04-13 | Traditional | PDF ↗ |
Product code ESW · Class II · General, Plastic Surgery. Data: openFDA.