510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261978Substantially Equivalent

WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System

Boston Scientific Corporation, Marlboro MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261978 is the FDA 510(k) clearance record for WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System, a class II device, cleared for Boston Scientific Corporation on under FDA product code ESW (Prosthesis, Esophageal). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K261978.

Clearance record

Decision date
Received
(28 days to decision)
Product code
ESW Prosthesis, Esophageal
Regulation
21 CFR 878.3610
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Boston Scientific Corporation 300 Boston Scientific Way, Marlboro MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ESW

Trailing 12 months
1 clearance under product code ESW in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ESW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260