Product code FCN— Gastroenterology, Urology

FDA has cleared 10 devices under product code FCN between 1977 and 1995, filed by 9 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.

• 19952 clearances
• 19941 clearance
• 19921 clearance
• 19891 clearance
• 19882 clearances
• 19781 clearance
• 19772 clearances

• Medical Inventors Corp., Inc.2 clearances
• Trinity Laboratories, Inc.1 clearance
• Terumo America, Inc.1 clearance
• Mentor Corp.1 clearance
• Medical Devices, Inc.1 clearance
• Lake Medical Products, Inc.1 clearance
• Knight Medical, Inc.1 clearance
• Kendall Research Center1 clearance
• Catco Medical, Inc.1 clearance

• K951443 — STANDARD FOLEY SYSTEM PAKTrinity Laboratories, Inc.·1995-06-15
• K945258 — CATCO URINARY COLLECTION KITCatco Medical, Inc.·1995-02-16
• K915166 — MICROCYCLERMedical Inventors Corp., Inc.·1994-09-07
• K922346 — FEMALE URINE SAMPLING DEVICEMentor Corp.·1992-08-14
• K890096 — BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAGMedical Inventors Corp., Inc.·1989-07-14
• K883886 — DOUBLE CLOSED URINARY DRAINAGE SYSTEMKnight Medical, Inc.·1988-12-19
• K883610 — LAKE FOLEY CATHETERIZATION TRAYLake Medical Products, Inc.·1988-10-12
• K780134 — URINARY DRAINAGE MONITORING SYSTEMMedical Devices, Inc.·1978-02-02
• K772133 — URINE SPECIMEN COLLECTING DEVICEKendall Research Center·1977-11-28
• K771210 — UROGARD URINARY DRAINAGE BAGTerumo America, Inc.·1977-07-11