DeviceClearance

Product code EZD— Gastroenterology, Urology

CURE CATHETER

Classification name
Catheter, Straight
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Total cleared
86
First cleared
Most recent

Market context for product code EZD

FDA has cleared 86 devices under product code EZD between 1978 and 2026, filed by 49 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code EZD

Adverse events under product code EZD

product code EZD
Injury
864
Malfunction
2,210
Total
3,074

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code EZD

Data sourced from openFDA. This site is unofficial and independent of the FDA.