510(k) K233837 ยท ESW Prosthesis, Esophageal
Agile Esophageal Stent System
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Apr 4, 2024 |
| Received | Dec 4, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.