Aer-O-Scope Colonoscope System— 510(k) K161791

Substantially Equivalent

Gi View , Ltd.

FDA 510(k) clearance K161791 for Aer-O-Scope Colonoscope System, Substantially Equivalent on 2016-08-11. Applicant: Gi View , Ltd..

Clearance details

Applicant: Gi View , Ltd.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2016-06-29
Decision date: 2016-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ramat Gan, 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.