510(k) K181437— Pure Vu System

Substantially Equivalent

Motus GI Medical Technologies , Ltd.

Clearance details

Applicant: Motus GI Medical Technologies , Ltd.
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2018-06-01
Decision date: 2018-06-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Tirat Carmel, 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.