FCN · Class II · 21 CFR 876.5250

FDA Product Code FCN: Urinary Drainage Collection Kit, For Indwelling Catheter

Leading manufacturers include Terumo America, Inc., Medical Devices, Inc. and Mentor Corp..

10
Total
10
Cleared
167d
Avg days
1977
Since

FDA 510(k) Cleared Urinary Drainage Collection Kit, For Indwelling Catheter Devices (Product Code FCN)

10 devices
1–10 of 10
Cleared Jun 15, 1995
STANDARD FOLEY SYSTEM PAK
K951443
Trinity Laboratories, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 14, 1992
FEMALE URINE SAMPLING DEVICE
K922346
Mentor Corp.
Gastroenterology & Urology · 87d
Cleared Feb 02, 1978
URINARY DRAINAGE MONITORING SYSTEM
K780134
Medical Devices, Inc.
Gastroenterology & Urology · 9d
Cleared Jul 11, 1977
UROGARD URINARY DRAINAGE BAG
K771210
Terumo America, Inc.
Gastroenterology & Urology · 6d

About Product Code FCN - Regulatory Context