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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 16, 2024 | Cardinal Health 200, LLC Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYD Open, Classified |
FCN | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN
Catalog # CKF105L Open, Classified |
FCN | None listed |
| Jun 23, 2014 | SteriGear, LLC SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO
Urinary Drainage Col Terminated |
FCN | None listed |
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