510(k) K261658— LoFric Origo Pro Coudé

Substantially Equivalent

Wellspect AB

Clearance details

Applicant: Wellspect AB
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2026-05-19
Decision date: 2026-07-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Mölndal, SE

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.