Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ESW — Predicate Candidate Screening
60 FDA 510(k) clearances under this product code; the 50 most recent screened below.
109 daysmedian FDA review time
408 days90th percentile
60clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-W | Boston Scientific Corporation | 2026-07-10 | 28 | 0 |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2025-10-30 | 342 | 0 |
| K253327 | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | 2025-10-30 | 30 | 0 |
| K251265 | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | 2025-07-23 | 90 | 0 |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal St | Boston Scientific | 2024-04-29 | 137 | 22 |
| K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | 2024-04-04 | 122 | 9 |
| K240522 | Esophageal TTS Stent | Taewoong Medical | 2024-03-22 | 28 | 0 |
| K223266 | Hilzo Esophageal Stents | Thoracent, Inc. | 2024-01-16 | 449 | 0 |
| K221482 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2022-06-22 | 30 | 0 |
| K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | 2021-11-22 | 151 | 0 |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | 2021-11-18 | 49 | 0 |
| K211706 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2021-10-08 | 127 | 0 |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | 2021-07-23 | 449 | 0 |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS ( | M.I.Tech Co., Ltd. | 2020-05-20 | 49 | 0 |
| K182910 | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2019-05-29 | 224 | 0 |
| K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018-09-21 | 246 | 0 |
| K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2018-05-18 | 242 | 0 |
| K162717 | Evolution Esophageal Stent System – Partially Covered | Cook Ireland, Ltd. | 2016-12-21 | 83 | 0 |
| K130004 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2013-12-06 | 338 | 0 |
| K123205 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2013-10-09 | 362 | 0 |
| K120983 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2012-05-02 | 30 | 0 |
| K113551 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2012-02-14 | 75 | 0 |
| K111611 | ENDOMAXX FULLY COVERED ESOPHAGEAL STENT | Merit Medical Systems, Inc. | 2011-07-29 | 50 | 0 |
| K093619 | EVOLUTION ESOPHAGEAL STENT FULLY COVERED, MODELS EVO-FC-18-2 | Cook Ireland, Ltd. | 2010-06-17 | 206 | 0 |
| K093537 | HANAROSTENT ESOPHAGUS (CCC) | M.I.Tech Co., Ltd. | 2010-06-04 | 200 | 0 |
| K092144 | BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEA | Endochoice, Inc. | 2010-02-22 | 222 | 0 |
| K091816 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2009-07-01 | 13 | 9 |
| K091510 | WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M0051 | Boston Scientific Corporation | 2009-06-26 | 35 | 0 |
| K080782 | NITI-S ESOPHAGEAL STENT | Taewoong Medical Co., Ltd. | 2009-01-30 | 317 | 0 |
| K072094 | CHOOSTENT | M.I.Tech Co., Ltd. | 2008-09-25 | 423 | 0 |
| K080332 | POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, | Boston Scientific Corporation | 2008-09-05 | 211 | 0 |
| K080359 | EVOLUTION ESOPHAGEAL STENT SYSTEM | Cook Ireland, Ltd. | 2008-05-09 | 88 | 0 |
| K080838 | ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | Alveolus, Inc. | 2008-04-24 | 30 | 0 |
| K073266 | WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM | Boston Scientific Corp | 2008-02-27 | 99 | 0 |
| K060239 | ALEOLUS/ENOVENTIONS,ALIMAXX-E DV ESOPHAGEAL STENT SYSTEM | Alveolus, Inc. | 2006-03-22 | 50 | 0 |
| K051621 | ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM | Alveolus, Inc. | 2005-07-11 | 21 | 0 |
| K041648 | NITI-S STENT & INTRODUCER, MODEL EOXXXX | Taewoong Medical Co., Ltd. | 2005-04-28 | 315 | 0 |
| K032930 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corp | 2003-10-23 | 31 | 16 |
| K030559 | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY | Rusch Intl. | 2003-06-30 | 129 | 0 |
| K011591 | ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE | Wilson-Cook Medical, Inc. | 2002-07-19 | 421 | 0 |
| K012883 | ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY | Boston Scientific Corp | 2001-10-12 | 45 | 46 |
| K003173 | ASPIRE COVERED STENT AND DELIVERY CATHETER | Vascular Architects, Inc. | 2001-03-13 | 154 | 0 |
| K010068 | RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTE | Rusch Intl. | 2001-02-08 | 31 | 9 |
| K002094 | BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE | C.R. Bard, Inc. | 2000-10-06 | 87 | 0 |
| K984068 | FLAMINGO WALLSTENT ESOPHAGEAL ENDOPROSTHESIS | Schneider (Europe) GmbH | 1999-01-07 | 52 | 0 |
| K983297 | MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM WITH SL | Medtronic Instent, Inc. | 1998-12-18 | 88 | 0 |
| K973584 | MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESO | Medtech Instruments | 1998-01-09 | 109 | 0 |
| K955041 | INSTENT ESOPHACOIL SELF-EXPANDING STENT SYSTEM | Instent, Inc. | 1996-02-21 | 110 | 0 |
| K955347 | ULTRAFLEX | Boston Scientific Corp | 1996-02-16 | 87 | 0 |
| K941487 | INSTENT ESOPHACOIL ESOPHAGEAL PROSTHESIS | Instent, Inc. | 1995-02-23 | 332 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda