DeviceClearance

Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System— 510(k) K233939

Substantially Equivalent

Boston Scientific

FDA 510(k) clearance K233939 for Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System, Substantially Equivalent on 2024-04-29. Applicant: Boston Scientific. Device class: 2.

Clearance details

Applicant
Boston Scientific
Product code
Code ESW
Device class
Class 2
Regulation
21 CFR 878.3610
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Marborough, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code ESW

product code ESW
Death
11
Injury
353
Malfunction
442
Total
806

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K233939

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K233939.

Data sourced from openFDA. This site is unofficial and independent of the FDA.