K041648

Substantially Equivalent

NITI-S STENT & INTRODUCER, MODEL EOXXXX

Applicant: Taewoong Medical Co., Ltd.
Product code: ESW
Advisory panel: General, Plastic Surgery
Date received: 2004-06-17
Decision date: 2005-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.