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 |