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
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
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
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
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
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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