Panels › General, Plastic Surgery › Product code ESW · Class 2
Prosthesis, Esophageal
Regulation 878.3610
1510(k)s in 12 months (60 all time)
0recalls in 12 months (67 all time)
67recalls that name a 510(k)
Top companies in ESW
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific | 15 | 65 |
| Taewoong Medical | 8 | 1 |
| M.I.Tech Co., Ltd. | 6 | 0 |
| Wilson-Cook Medical, Inc. | 3 | 1 |
| Alveolus, Inc. | 3 | 0 |
| Cook Ireland, Ltd. | 3 | 0 |
| Boston Scientific Scimed, Inc. | 2 | 0 |
| Cook, Inc. | 2 | 0 |
| Hood Laboratories | 2 | 0 |
| Instent, Inc. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2024 | Boston Scientific Corporation AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F-
Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictur Open, Classified |
ESW | K233837 |
| Sep 26, 2024 | Boston Scientific Corporation AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal stricture Open, Classified |
ESW | K233837 |
| Sep 26, 2024 | Boston Scientific Corporation AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal stricture Open, Classified |
ESW | K233837 |
| Sep 26, 2024 | Boston Scientific Corporation AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal stricture Open, Classified |
ESW | K233837 |
| Sep 26, 2024 | Boston Scientific Corporation AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal stricture Open, Classified |
ESW | K233837 |
| Sep 26, 2024 | Boston Scientific Corporation AGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal stricture Open, Classified |
ESW | K233837 |
| Sep 26, 2024 | Boston Scientific Corporation AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal stricture Open, Classified |
ESW | K233837 |
| Sep 26, 2024 | Boston Scientific Corporation AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal stricture Open, Classified |
ESW | K233837 |
| Sep 26, 2024 | Boston Scientific Corporation AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictu Open, Classified |
ESW | K233837 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX PC ESOPH STENT 18/23MM X 153MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX PC ESOPH STENT 18/23MM X 123MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intri Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intr Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intr Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures cau Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX ESOPHAGEAL FC 18/23-25MMX10CM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caus Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused b Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent eso Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused b Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused b Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX FC ESO STENT RMV 23X105MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused b Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by Open, Classified |
ESW | K233939 |
| Sep 26, 2024 | Boston Scientific Corporation WALLFLEX FC ESO STENT RMV 18X103MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused b Open, Classified |
ESW | K233939 |
| Oct 18, 2019 | Taewoong Medical Co., Ltd. Niti-S Esophageal Stent, REF ES1806F, ES1808F, ES1810F, ES1815F, ES2006B, ES2010B, ES1612B, ES1615B, ES1810B, ES1812B, ES1815B, ES1610F, ES1612F, ES1615F, ES2006F, ES2008F, ES2010F;
Esophageal TTS St Terminated |
ESW | K080782 K113551 +1 |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Large Esophageal Stent System - Proximal Release (23/28/12/9)
Material/UPN/Catalog Number: M00514250 Terminated |
ESW | K091816 |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Uncovered Large Esophageal Stent System - Distal Release (23/28/12)
Material/UPN/Catalog Number: M00514230 Terminated |
ESW | K091816 |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered large Esophageal Stent System - Distal Release (23/28/10/7)
Material/UPN/Catalog Number: M00514200 Terminated |
ESW | K091816 |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/15/12)
Material/UPN/Catalog Number: M00513860 Terminated |
ESW | K091816 |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/12/9)
Material/UPN/Catalog Number: M00513850 Terminated |
ESW | K091816 |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Esophageal Stent System - Proximal Release (18/23/10/7)
Material/UPN/Catalog Number: M00513840 Terminated |
ESW | K091816 |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Uncovered Esophageal Stent System - Proximal Release (18/23/7) Material/UPN/Catalog Number: M00513800 Terminated |
ESW | K091816 |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Covered Esophageal Stent System - Distal Release Distal Release (18/23/12/9)
Material/UPN/Catalog Number: M00513740 Terminated |
ESW | K091816 |
| Aug 31, 2010 | Boston Scientific Corporation Boston Scientific Ultraflex Uncovered Esophageal Stent System - Distal Release (18/23/15)
Material/Catalog Number: M00513720. Terminated |
ESW | K091816 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Large - Proximal Release - 23/28/12/9. Catalog Number M00514250. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esoph Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Large - Proximal Release - 23/28/10/7. Catalog Number M00514240. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esoph Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Large - Distal Release - 23/28/12/9. Catalog Number M00514210. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophag Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Large - Distal Release - 23/28/10/7. Catalog Number M00514200. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophag Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/15/12. Catalog Number M00513860. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal l Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/12/9. Catalog Number M00513850. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lu Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Covered - Proximal Release - 18/23/10/7. Catalog Number M00513840. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lu Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/15. Catalog Number M00513830. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lu Terminated |
ESW | K032930 |
| Jun 25, 2010 | Boston Scientific Corporation Ultraflex Esophageal Stent System. Uncovered - Proximal Release - 18/23/10. Catalog Number M00513810. Single Use, Rx only. Boston Scientific, Natick, MA 01760.
Intended for maintaining esophageal lu Terminated |
ESW | K032930 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.