SUPERCATH 5— 510(k) K081953

Substantially Equivalent

Togo Medikit Co., Ltd.

FDA 510(k) clearance K081953 for SUPERCATH 5, Substantially Equivalent on 2009-03-12. Applicant: Togo Medikit Co., Ltd..

Clearance details

Applicant: Togo Medikit Co., Ltd.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2008-07-09
Decision date: 2009-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.