Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System

K-Number: K233939 · 2024-04-29

ApplicantBoston Scientific
Decision Date2024-04-29
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System is a medical device manufactured by Boston Scientific. It received FDA 510(k) clearance on 2024-04-29 under approval number K233939. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System?

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System is a medical device that received FDA 510(k) clearance on 2024-04-29. It is manufactured by Boston Scientific. The 510(k) number is K233939.

When was Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System approved by the FDA?

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System received FDA 510(k) clearance on 2024-04-29, under approval number K233939.

What company makes Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System?

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System is manufactured by Boston Scientific.

What is the FDA product code for Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System?

The FDA product code for Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System is ESW.

Related Clinical Trials

NCT03736226 A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China ACTIVE_NOT_RECRUITING NCT06170606 POLARx Post Approval Study (POLARx PAS) ACTIVE_NOT_RECRUITING NCT07611968 Prospective Evaluation of Physician Modified Endografts for Aortic Disease NOT_YET_RECRUITING NCT05864560 Ankura™ AAA, Cuff and AUI Stent Graft System Post-Market Clinical Follow-Up ACTIVE_NOT_RECRUITING NCT05639569 Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study ACTIVE_NOT_RECRUITING NCT06710938 Thoracoabdominal Artery Stent Graft System Exploratory Study RECRUITING

Other Devices by Boston Scientific

K160751Symphion Endoscope and Symphion Cervical Sheath DEN150040WallFlex Biliary RX Fully Covered Stent System RMV K173184Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle K163058Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle K180068ORISE Gel K180864WATCHMAN TruSeal Access System

View all 43 devices →

Related Devices (Code: ESW)

K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd. K180144Agile Esophageal Stent SystemBoston Scientific Corporation K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd. K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑