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FCN — Urinary Drainage Collection Kit, For Indwelling Catheter Class II

FDA Device Classification

Classification Details

Product Code
FCN
Device Class
Class II
Regulation Number
876.5250
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K951443trinity laboratoriesSTANDARD FOLEY SYSTEM PAKJune 15, 1995
K945258catco medicalCATCO URINARY COLLECTION KITFebruary 16, 1995
K915166medical inventors corpMICROCYCLERSeptember 7, 1994
K922346mentorFEMALE URINE SAMPLING DEVICEAugust 14, 1992
K890096medical inventors corpBLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAGJuly 14, 1989
K883886knight medicalDOUBLE CLOSED URINARY DRAINAGE SYSTEMDecember 19, 1988
K883610lake medical productsLAKE FOLEY CATHETERIZATION TRAYOctober 12, 1988
K780134medical devicesURINARY DRAINAGE MONITORING SYSTEMFebruary 2, 1978
K772133kendall research centerURINE SPECIMEN COLLECTING DEVICENovember 28, 1977
K771210terumo americaUROGARD URINARY DRAINAGE BAGJuly 11, 1977