Clearance Summary
WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System received FDA 510(k) clearance under submission number K261978, sponsored by Boston Scientific Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2026-07-10.
- Submission: K261978
- Applicant / Sponsor: Boston Scientific Corporation
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.3610
- Decision date: 2026-07-10
Classification & Regulation
This clearance is catalogued under FDA product code ESW and 21 CFR 878.3610, within the General, Plastic Surgery review panel as a Class II device.