TORNADO ROTATABEL SNARE AND POLYP CATCHER— 510(k) K083049

Substantially Equivalent

Horizons Intl. Corp.

FDA 510(k) clearance K083049 for TORNADO ROTATABEL SNARE AND POLYP CATCHER, Substantially Equivalent on 2008-12-23. Applicant: Horizons Intl. Corp..

Clearance details

Applicant: Horizons Intl. Corp.
Product code: Code FDI
Advisory panel: Gastroenterology, Urology
Date received: 2008-10-14
Decision date: 2008-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barreal De Heredia, CR

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Adverse events under product code FDI

product code FDI

Death: 6
Injury: 217
Malfunction: 1,544
Total: 1,767

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.