CLEARPATH LOWER GI— 510(k) K113050

Substantially Equivalent

Easyglide , Ltd.

FDA 510(k) clearance K113050 for CLEARPATH LOWER GI, Substantially Equivalent on 2012-05-16. Applicant: Easyglide , Ltd..

Clearance details

Applicant: Easyglide , Ltd.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2011-10-13
Decision date: 2012-05-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Bonita Springs, FL, US

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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.