510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K233939Substantially Equivalent

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System

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

K233939 is the FDA 510(k) clearance record for Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System, a class II device, cleared for Boston Scientific on under FDA product code ESW (Prosthesis, Esophageal). FDA records list 1,110 510(k) clearances for Boston Scientific, from to . As of , FDA records show 22 recalls naming K233939.

Clearance record

Decision date
Received
(137 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 300 Boston Scientific Way, Marborough 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