510(k) K102616— NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE

Substantially Equivalent

Smart Medical Systems , Ltd.

Clearance details

Applicant: Smart Medical Systems , Ltd.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2010-09-10
Decision date: 2010-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raanana, IL

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.