G-EYE System— 510(k) K220158

Substantially Equivalent

Smart Medical Systems , Ltd.

FDA 510(k) clearance K220158 for G-EYE System, Substantially Equivalent on 2022-04-11. Applicant: Smart Medical Systems , Ltd..

Clearance details

Applicant: Smart Medical Systems , Ltd.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2022-01-19
Decision date: 2022-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ra'Anana, IL

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.