K052267

Substantially Equivalent

SUPERCATH V

Applicant: Togo Medikit Co., Ltd.
Product code: FIE
Advisory panel: Gastroenterology, Urology
Date received: 2005-08-19
Decision date: 2006-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Adverse events under product code FIE

product code FIE

Death: 2
Total: 2

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.