ClearanceBrief
510(k) K233939 ยท ESW Prosthesis, Esophageal

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System

ApplicantBoston Scientific, Marborough MA, US
DecisionSubstantially Equivalent, Apr 29, 2024
ReceivedDec 14, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K233939

DateFirm and productCodeLinked 510(k)
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed
Sep 26, 2024Boston 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
ESWNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.