DeviceClearance

Product code FCM— Gastroenterology, Urology

FOLEY CATHETERIZATION TRAY

Classification name
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Device class
Class 2
Regulation
21 CFR 876.5130
Advisory panel
Gastroenterology, Urology
Total cleared
60
First cleared
Most recent

Market context for product code FCM

FDA has cleared 60 devices under product code FCM between 1976 and 2026, filed by 33 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 FCM

Recent clearances under product code FCM

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