DeviceClearance

Product code EZL— Gastroenterology, Urology

2-Way 100% Silicone Cleartract Catheter

Classification name
Catheter, Retention Type, Balloon
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Total cleared
130
First cleared
Most recent

Market context for product code EZL

FDA has cleared 130 devices under product code EZL between 1977 and 2026, filed by 81 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 EZL

Adverse events under product code EZL

product code EZL
Death
6
Injury
796
Malfunction
4,989
Other
1
Total
5,792

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 EZL

1–100 of 130

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