FCN — Urinary Drainage Collection Kit, For Indwelling Catheter Class II
FDA product code FCN covers "Urinary Drainage Collection Kit, For Indwelling Catheter", a Class II medical device regulated under 21 CFR 876.5250. Submissions are reviewed by the Gastroenterology, Urology panel. At least 10 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K951443 | trinity laboratories | STANDARD FOLEY SYSTEM PAK | June 15, 1995 |
| K945258 | catco medical | CATCO URINARY COLLECTION KIT | February 16, 1995 |
| K915166 | medical inventors corp | MICROCYCLER | September 7, 1994 |
| K922346 | mentor | FEMALE URINE SAMPLING DEVICE | August 14, 1992 |
| K890096 | medical inventors corp | BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG | July 14, 1989 |
| K883886 | knight medical | DOUBLE CLOSED URINARY DRAINAGE SYSTEM | December 19, 1988 |
| K883610 | lake medical products | LAKE FOLEY CATHETERIZATION TRAY | October 12, 1988 |
| K780134 | medical devices | URINARY DRAINAGE MONITORING SYSTEM | February 2, 1978 |
| K772133 | kendall research center | URINE SPECIMEN COLLECTING DEVICE | November 28, 1977 |
| K771210 | terumo america | UROGARD URINARY DRAINAGE BAG | July 11, 1977 |