DiLumen C2 and Tool Mount— 510(k) K211819

Substantially Equivalent

Lumendi, LLC

FDA 510(k) clearance K211819 for DiLumen C2 and Tool Mount, Substantially Equivalent on 2021-10-22. Applicant: Lumendi, LLC.

Clearance details

Applicant: Lumendi, LLC
Product code: Code FDF
Advisory panel: Gastroenterology, Urology
Date received: 2021-06-11
Decision date: 2021-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westport, CT, US

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.