Focus Cap— 510(k) K171673

Substantially Equivalent

Gce Medical Corporation

FDA 510(k) clearance K171673 for Focus Cap, Substantially Equivalent on 2018-01-19. Applicant: Gce Medical Corporation.

Clearance details

Applicant: Gce Medical Corporation
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2017-06-06
Decision date: 2018-01-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fresno, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FDF

product code FDF

Death: 8
Injury: 729
Malfunction: 61,773
Total: 62,510

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.