DeviceClearance

Product code EYC— Gastroenterology, Urology

EXAC-TEMP & CLINI-TEMP FOLEY CATHETER'S

Classification name
Catheter, Upper Urinary Tract
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Total cleared
5
First cleared
Most recent

Market context for product code EYC

FDA has cleared 5 devices under product code EYC between 1989 and 2020, filed by 4 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

Top applicants under product code EYC

Recent clearances under product code EYC

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