K132500

Substantially Equivalent

CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED

Applicant: Cure Medical, LLC
Product code: EZD
Advisory panel: Gastroenterology, Urology
Date received: 2013-08-09
Decision date: 2013-12-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Henderson, NV, 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.