K052440

Substantially Equivalent

MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER

Applicant: Mentor Corporation
Product code: EZD
Advisory panel: Gastroenterology, Urology
Date received: 2005-09-06
Decision date: 2005-10-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Santa Barbara, CA, US

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.