Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)— 510(k) K241028

Substantially Equivalent

Coloplast

FDA 510(k) clearance K241028 for Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056), Substantially Equivalent on 2024-07-26. Applicant: Coloplast.

Clearance details

Applicant: Coloplast
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2024-04-15
Decision date: 2024-07-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

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.