ENDOMAXX FULLY COVERED ESOPHAGEAL STENT— 510(k) K111611

Substantially Equivalent

Merit Medical Systems, Inc.

FDA 510(k) clearance K111611 for ENDOMAXX FULLY COVERED ESOPHAGEAL STENT, Substantially Equivalent on 2011-07-29. Applicant: Merit Medical Systems, Inc..

Clearance details

Applicant: Merit Medical Systems, Inc.
Product code: Code ESW
Advisory panel: General, Plastic Surgery
Date received: 2011-06-09
Decision date: 2011-07-29
Decision: Substantially Equivalent
Clearance type: Special
Location: South Jordan, UT, US

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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, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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