Panels › Gastroenterology, Urology › Product code FCN · Class 2
Urinary Drainage Collection Kit, For Indwelling Catheter
Regulation 876.5250
0510(k)s in 12 months (10 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in FCN
| Company | 510(k)s | Recalls |
|---|---|---|
| Medical Inventors Corp., Inc. | 2 | 0 |
| Cardinal Health 200, LLC | 0 | 1 |
| Catco Medical, Inc. | 1 | 0 |
| Kendall Research Center | 1 | 0 |
| Knight Medical, Inc. | 1 | 0 |
| Lake Medical Products, Inc. | 1 | 0 |
| Mckesson Medical-Surgical Inc. Corporate Office | 0 | 1 |
| Medical Devices, Inc. | 1 | 0 |
| Mentor Corp. | 1 | 0 |
| SteriGear, LLC | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 1995 | K951443 | STANDARD FOLEY SYSTEM PAK Trinity Laboratories, Inc. | FCN |
| Feb 16, 1995 | K945258 | CATCO URINARY COLLECTION KIT Catco Medical, Inc. | FCN |
| Sep 7, 1994 | K915166 | MICROCYCLER Medical Inventors Corp., Inc. | FCN |
| Aug 14, 1992 | K922346 | FEMALE URINE SAMPLING DEVICE Mentor Corp. | FCN |
| Jul 14, 1989 | K890096 | BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG Medical Inventors Corp., Inc. | FCN |
| Dec 19, 1988 | K883886 | DOUBLE CLOSED URINARY DRAINAGE SYSTEM Knight Medical, Inc. | FCN |
| Oct 12, 1988 | K883610 | LAKE FOLEY CATHETERIZATION TRAY Lake Medical Products, Inc. | FCN |
| Feb 2, 1978 | K780134 | URINARY DRAINAGE MONITORING SYSTEM Medical Devices, Inc. | FCN |
| Nov 28, 1977 | K772133 | URINE SPECIMEN COLLECTING DEVICE Kendall Research Center | FCN |
| Jul 11, 1977 | K771210 | UROGARD URINARY DRAINAGE BAG Terumo America, Inc. | FCN |
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