DiLumen Endolumenal Interventional Scissors (DiLumen Is)— 510(k) K173405

Substantially Equivalent

Lumendi, LLC

FDA 510(k) clearance K173405 for DiLumen Endolumenal Interventional Scissors (DiLumen Is), Substantially Equivalent on 2018-05-22. Applicant: Lumendi, LLC.

Clearance details

Applicant: Lumendi, LLC
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2017-10-31
Decision date: 2018-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westport, CT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.