Product code ESW
- Device name
- Prosthesis, Esophageal
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.3610
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253327 | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | 2025-10-30 |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2025-10-30 |
| K251265 | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | 2025-07-23 |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | 2024-04-29 |
| K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | 2024-04-04 |
| K240522 | Esophageal TTS Stent | Taewoong Medical | 2024-03-22 |
| K223266 | Hilzo Esophageal Stents | Thoracent, Inc. | 2024-01-16 |
| K221482 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2022-06-22 |
| K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | 2021-11-22 |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | 2021-11-18 |
| K211706 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2021-10-08 |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | 2021-07-23 |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | M.I.Tech Co., Ltd. | 2020-05-20 |
| K182910 | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2019-05-29 |
| K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018-09-21 |
| K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2018-05-18 |
| K162717 | Evolution Esophageal Stent System – Partially Covered | Cook Ireland, Ltd. | 2016-12-21 |
| K130004 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2013-12-06 |
| K123205 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2013-10-09 |
| K120983 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2012-05-02 |
| K113551 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | 2012-02-14 |
| K111611 | ENDOMAXX FULLY COVERED ESOPHAGEAL STENT | Merit Medical Systems, Inc. | 2011-07-29 |
| 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 |
| K093537 | HANAROSTENT ESOPHAGUS (CCC) | M.I.Tech Co., Ltd. | 2010-06-04 |
| K092144 | BONASTENT ESOPHAGEAL, MODELS BE AND BER, BONASTENT ESOPHAGEAL U.E.S. FLANGE AND FLARE, MODELS BEFG AND BEFR | Endochoice, Inc. | 2010-02-22 |
| K091816 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | 2009-07-01 |
| K091510 | WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 | Boston Scientific Corporation | 2009-06-26 |
| K080782 | NITI-S ESOPHAGEAL STENT | Taewoong Medical Co., Ltd. | 2009-01-30 |
| K072094 | CHOOSTENT | M.I.Tech Co., Ltd. | 2008-09-25 |
| K080332 | POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 | Boston Scientific Corporation | 2008-09-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08800026612674 | HILZO Esophageal stents | BCM Co., Ltd. | 2024-06-19 |
| 08800026612667 | HILZO Esophageal stents | BCM Co., Ltd. | 2024-06-19 |
| 08800026612650 | HILZO Esophageal stents | BCM Co., Ltd. | 2024-06-19 |
| 08800026612643 | HILZO Esophageal stents | BCM Co., Ltd. | 2024-06-19 |
| 08800026612636 | HILZO Esophageal stents | BCM Co., Ltd. | 2024-06-19 |
| 08800026612629 | HILZO Esophageal stents | BCM Co., Ltd. | 2024-06-19 |
| 08800026612612 | HILZO Esophageal stents | BCM Co., Ltd. | 2024-06-19 |
| 08714729716136 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716204 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716198 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716181 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716174 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716167 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716150 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716143 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729121190 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716129 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716112 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716105 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716099 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716082 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729716075 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729649113 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204688 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204671 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204664 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729204633 | WALLSTENT™ BILIARY | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729121220 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729121213 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |
| 08714729121206 | Ultraflex™ Esophageal NG | BOSTON SCIENTIFIC CORPORATION | 2015-09-24 |