| WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (K261978) | Boston Scientific Corporation | 2026-07-10 |
| Niti-S Esophageal Stent; Esophageal TTS Stent (K243619) | Taewoong Medical Co., Ltd. | 2025-10-30 |
| HANAROSTENT Esophagus Upper (CCC) (K253327) | M.I.Tech Co., Ltd. | 2025-10-30 |
| Resilience Fully Covered Esophageal Stent System (K251265) | Merit Medical Systems, Inc. | 2025-07-23 |
| Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System (K233939) | Boston Scientific | 2024-04-29 |
| Agile Esophageal Stent System (K233837) | Boston Scientific Corporation | 2024-04-04 |
| Esophageal TTS Stent (K240522) | Taewoong Medical | 2024-03-22 |
| Hilzo Esophageal Stents (K223266) | Thoracent, Inc. | 2024-01-16 |
| Esophageal TTS Stent (K221482) | Taewoong Medical Co., Ltd. | 2022-06-22 |
| Agile Esophageal OTW Stent System (K211960) | Boston Scientific Corporation | 2021-11-22 |
| HANAROSTENT Esophagus Asymmetric (CCC) (K213251) | M.I.Tech Co., Ltd. | 2021-11-18 |
| Esophageal TTS Stent (K211706) | Taewoong Medical Co., Ltd. | 2021-10-08 |
| HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) (K201160) | M.I.Tech Co., Ltd. | 2021-07-23 |
| HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) (K200860) | M.I.Tech Co., Ltd. | 2020-05-20 |
| Segmented Esophageal Stent System (K182910) | Micro-Tech (Nanjing) Co., Ltd. | 2019-05-29 |
| Agile Esophageal Stent System (K180144) | Boston Scientific Corporation | 2018-09-21 |
| Esophageal Stent System (K172813) | Micro-Tech (Nanjing) Co., Ltd. | 2018-05-18 |
| Evolution Esophageal Stent System – Partially Covered (K162717) | Cook Ireland, Ltd. | 2016-12-21 |
| ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K130004) | Boston Scientific Corporation | 2013-12-06 |
| ESOPHAGEAL TTS STENT (K123205) | Taewoong Medical Co., Ltd. | 2013-10-09 |
| ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K120983) | Boston Scientific Corporation | 2012-05-02 |
| ESOPHAGEAL TTS STENT (K113551) | Taewoong Medical Co., Ltd. | 2012-02-14 |
| ENDOMAXX FULLY COVERED ESOPHAGEAL STENT (K111611) | Merit Medical Systems, Inc. | 2011-07-29 |
| EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-23-8-E, EVO-FC-18-23-10-E, EVO-FC-18-23-12-E (K093619) | Cook Ireland, Ltd. | 2010-06-17 |
| HANAROSTENT ESOPHAGUS (CCC) (K093537) | M.I.Tech Co., Ltd. | 2010-06-04 |
| BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR (K092144) | Endochoice, Inc. | 2010-02-22 |
| ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K091816) | Boston Scientific Corporation | 2009-07-01 |
| WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 (K091510) | Boston Scientific Corporation | 2009-06-26 |
| NITI-S ESOPHAGEAL STENT (K080782) | Taewoong Medical Co., Ltd. | 2009-01-30 |
| CHOOSTENT (K072094) | M.I.Tech Co., Ltd. | 2008-09-25 |
| POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 (K080332) | Boston Scientific Corporation | 2008-09-05 |
| EVOLUTION ESOPHAGEAL STENT SYSTEM (K080359) | Cook Ireland, Ltd. | 2008-05-09 |
| ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM (K080838) | Alveolus, Inc. | 2008-04-24 |
| WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM (K073266) | Boston Scientific Corp | 2008-02-27 |
| ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM (K060239) | Alveolus, Inc. | 2006-03-22 |
| ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM (K051621) | Alveolus, Inc. | 2005-07-11 |
| NITI-S STENT & INTRODUCER, MODEL EOXXXX (K041648) | Taewoong Medical Co., Ltd. | 2005-04-28 |
| ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM (K032930) | Boston Scientific Corp | 2003-10-23 |
| RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM (K030559) | Rusch Intl. | 2003-06-30 |
| ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE (K011591) | Wilson-Cook Medical, Inc. | 2002-07-19 |
| ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM (K012883) | Boston Scientific Corp | 2001-10-12 |
| ASPIRE COVERED STENT AND DELIVERY CATHETER (K003173) | Vascular Architects, Inc. | 2001-03-13 |
| RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM (K010068) | Rusch Intl. | 2001-02-08 |
| BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE (K002094) | C.R. Bard, Inc. | 2000-10-06 |
| FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS (K984068) | Schneider (Europe) GmbH | 1999-01-07 |
| MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SLOW RELEASE (K983297) | Medtronic Instent, Inc. | 1998-12-18 |
| MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM (K973584) | Medtech Instruments | 1998-01-09 |
| INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM (K955041) | Instent, Inc. | 1996-02-21 |
| ULTRAFLEX (K955347) | Boston Scientific Corp | 1996-02-16 |
| INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS (K941487) | Instent, Inc. | 1995-02-23 |
| COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT (K945201) | Cook, Inc. | 1995-01-04 |
| WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) (K940396) | Boston Scientific Scimed, Inc. | 1994-10-03 |
| WALLSTENT ESOPHAGEAL PROSTHESIS (K940395) | Boston Scientific Scimed, Inc. | 1994-09-20 |
| MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM (K940838) | Boston Scientific Corp | 1994-08-18 |
| ESOPHAGEAL Z-STENT (K920218) | Wilson-Cook Medical, Inc. | 1994-02-09 |
| WALLSTENT ESOPHAGEAL PROTHESIS (K923119) | Schneider U.S. Stent Div. | 1992-09-01 |
| ESOPHAGEAL Z-STENT (K914029) | Cook, Inc. | 1991-12-09 |
| ELIACHAR MODIFIED ESOPHAGEAL STENT (K904821) | Hood Laboratories | 1991-01-14 |
| WILSON-COOK ESOPHAGEAL BALLOON PROSTHESIS (K885309) | Wilson-Cook Medical, Inc. | 1990-02-09 |
| HOOD ESOPHAGEAL PROSTHESIS (K871244) | Hood Laboratories | 1987-04-13 |