FCN · Urinary Drainage Collection Kit, For Indwelling Catheter
Gastroenterology, Urology · 21 CFR 876.5250 · Class 2
Overview
| Product Code | FCN |
|---|---|
| Device Name | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Regulation | 21 CFR 876.5250 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and (2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
Classification Rationale
(1) Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Special Controls
*Classification* —(1)*Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter.* The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) *Class I (general controls).* For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K951443 | STANDARD FOLEY SYSTEM PAK | Trinity Laboratories, Inc. | Jun 15, 1995 | SESE |
| K945258 | CATCO URINARY COLLECTION KIT | Catco Medical, Inc. | Feb 16, 1995 | SEKD |
| K915166 | MICROCYCLER | Medical Inventors Corp., Inc. | Sep 7, 1994 | SESE |
| K922346 | FEMALE URINE SAMPLING DEVICE | Mentor Corp. | Aug 14, 1992 | SESE |
| K890096 | BLADDER CYCLER CLOSED-SYSTEM URINARY DRAIN BAG | Medical Inventors Corp., Inc. | Jul 14, 1989 | SESE |
| K883886 | DOUBLE CLOSED URINARY DRAINAGE SYSTEM | Knight Medical, Inc. | Dec 19, 1988 | SESE |
| K883610 | LAKE FOLEY CATHETERIZATION TRAY | Lake Medical Products, Inc. | Oct 12, 1988 | SESE |
| K780134 | URINARY DRAINAGE MONITORING SYSTEM | Medical Devices, Inc. | Feb 2, 1978 | SESE |
| K772133 | URINE SPECIMEN COLLECTING DEVICE | Kendall Research Center | Nov 28, 1977 | SESE |
| K771210 | UROGARD URINARY DRAINAGE BAG | Terumo America, Inc. | Jul 11, 1977 | SESE |
Top Applicants
- Medical Inventors Corp., Inc. — 2 clearances
- Catco Medical, Inc. — 1 clearance
- Kendall Research Center — 1 clearance
- Knight Medical, Inc. — 1 clearance
- Lake Medical Products, Inc. — 1 clearance
