FCM

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Product code

FCM

Device name

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Device class

Class 2

21 CFR

21 CFR 876.5130

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

60 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-05-29.

2 summaries are archived here for direct download.