Urinary Drainage Collection Kit, For Indwelling Catheter
The Urinary Drainage Collection Kit for Indwelling Catheter (product code FCN) is a packaged system of components used to collect and manage urine drainage from patients with an indwelling urinary catheter, designed to reduce the risk of infection. It is an FDA Class 2 device (moderate risk), subject to general controls with no 510(k) required under the applicable submission type. It is regulated under 21 CFR 876.5250 in the Gastroenterology and Urology specialty. No special flags apply.
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Basic Information
- Product Code
- FCN
- Device Class
- FDA class 2
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K951443 | STANDARD FOLEY SYSTEM PAK | Jun 15, 1995 | Substantially Equivalent | Trinity Laboratories, Inc. |
| K945258 | CATCO URINARY COLLECTION KIT | Feb 16, 1995 | Unknown | Catco Medical, Inc. |
| K915166 | MICROCYCLER | Sep 07, 1994 | Substantially Equivalent | Medical Inventors Corp., Inc. |
| K922346 | FEMALE URINE SAMPLING DEVICE | Aug 14, 1992 | Substantially Equivalent | Mentor Corp. |
| K890096 | BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG | Jul 14, 1989 | Substantially Equivalent | Medical Inventors Corp., Inc. |
| K883886 | DOUBLE CLOSED URINARY DRAINAGE SYSTEM | Dec 19, 1988 | Substantially Equivalent | Knight Medical, Inc. |
| K883610 | LAKE FOLEY CATHETERIZATION TRAY | Oct 12, 1988 | Substantially Equivalent | Lake Medical Products, Inc. |
| K780134 | URINARY DRAINAGE MONITORING SYSTEM | Feb 02, 1978 | Substantially Equivalent | Medical Devices, Inc. |
| K772133 | URINE SPECIMEN COLLECTING DEVICE | Nov 28, 1977 | Substantially Equivalent | Kendall Research Center |
| K771210 | UROGARD URINARY DRAINAGE BAG | Jul 11, 1977 | Substantially Equivalent | Terumo America, Inc. |
FEI Numbers
This FDA classification entry is associated with 56 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 56 registration numbers. Click on an entry to view related FDA registrations.