Super Sheath— 510(k) K200379

Substantially Equivalent

Togo Medikit Co., Ltd.

FDA 510(k) clearance K200379 for Super Sheath, Substantially Equivalent on 2020-03-19. Applicant: Togo Medikit Co., Ltd..

Clearance details

Applicant: Togo Medikit Co., Ltd.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2020-02-18
Decision date: 2020-03-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Hyuga City, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRE

product code DRE

Death: 100
Injury: 832
Malfunction: 597
Other: 3
Total: 1,532

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.