510(k) K233939 ยท ESW Prosthesis, Esophageal
Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System
| Applicant | Boston Scientific, Marborough MA, US |
| Decision | Substantially Equivalent, Apr 29, 2024 |
| Received | Dec 14, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233939
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.