KNX · Collector, Urine, (And Accessories) For Indwelling Catheter
Gastroenterology, Urology · 21 CFR 876.5250 · Class 2
Overview
| Product Code | KNX |
|---|---|
| Device Name | Collector, Urine, (And Accessories) 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 (20 of 206)
Showing 20 most recent of 206 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110518 | IBAG | Future Path Medical, LLC | Jun 24, 2011 | SESE |
| K973364 | 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG | Maersk Medical A/S | Mar 17, 1998 | SESE |
| K972887 | MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG | Medline Industries, Inc. | Dec 11, 1997 | SESE |
| K971271 | BESECURE EXTERNAL URINARY COLLECTION SYSTEM | Urology Research Intl., Inc. | Aug 18, 1997 | SESE |
| K971929 | AMSINO URINARY LEG BAG | Amsino Intl., Inc. | Aug 6, 1997 | SESE |
| K971764 | WELCON HUE-VU URINARY DRAINAGE BAG | Welcon, Inc. | Jul 29, 1997 | SESE |
| K964690 | LIBERTY VALVE | Cleveland Medical Devices, Inc. | Mar 21, 1997 | SESE |
| K964745 | AMSINO URINARY DRAINAGE BAG | Amsino Intl., Inc. | Mar 18, 1997 | SESE |
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) | Customed, Inc. | Oct 4, 1996 | SESE |
| K960949 | PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 | Bristol-Myers Squibb | Apr 19, 1996 | SESE |
| K952208 | PROSYS LEG BAG | Convatec, A Division of E.R. Squibb & Sons | Aug 15, 1995 | SESE |
| K944377 | ORION'S URINARY DRAINAGE SET | Regulatory & Marketing Services, Inc. | Dec 6, 1994 | SESE |
| K944236 | NEEDLELESS URINE SAMPLING PORT | Kendall Healthcare Products Co. Div.Of Tyco Health | Nov 16, 1994 | SESE |
| K940206 | BARD URINE COLLECTION PRODUCTS MODIFICATION | C.R. Bard, Inc. | Sep 16, 1994 | SESE |
| K941447 | SIMPLA S4, S5, S7 | Simpla Plastics , Ltd. | Jul 18, 1994 | SESE |
| K935557 | URINARY DRAINAGE BAG | Puritas Health Care, Inc. | Mar 7, 1994 | SESE |
| K931459 | KENGUARD URINARY DRAINAGE BAG W/ANTIREFLUX CHAMBER | Kendall Healthcare Products Co. Div.Of Tyco Health | Jun 14, 1993 | SESE |
| K925067 | SIMPLA TRIDENT LEG BAG + SIMPLA S6 BAG | Simport Plastics, Ltd. | Jun 10, 1993 | SESE |
| K926570 | HOLLISTER(R) BEDSIDE DRAINAGE COLLECTION SYST 9878 | Hollister, Inc. | May 21, 1993 | SESE |
| K921024 | URO-TOTE LEG BAG | Neotech Products, Inc. | Sep 2, 1992 | SESE |
Top Applicants
- Bio D Corp. — 9 clearances
- Conphar, Inc. — 6 clearances
- The Kendal Co. — 6 clearances
- Coloplast A/S — 5 clearances
- Concord Laboratories, Inc. — 5 clearances
