Urinary Drainage Unit
FDA 510(k) K890551 · Consolidated Products & Services, Inc.
510(k) numberK890551
Submission
- Device name
- Urinary Drainage Unit
- Applicant
- Consolidated Products & Services, Inc.
North Quincy, MA, US - Received
- February 6, 1989
- Decision date
- February 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KNX – Collector, Urine, (And Accessories) For Indwelling Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5250
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KNX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K110518 | IbagKNX · Traditional | Future Path Medical, LLC | 06/24/2011SE |
| K973364 | 4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage BagKNX · Traditional | Maersk Medical A/S | 03/17/1998SE |
| K972887 | Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg BagKNX · Traditional | Medline Industries, Inc. | 12/11/1997SE |
| K971271 | Besecure External Urinary Collection SystemKNX · Traditional | Urology Research Intl., Inc. | 08/18/1997SE |
| K971929 | Amsino Urinary Leg BagKNX · Traditional | Amsino Intl., Inc. | 08/06/1997SE |
| K971764 | Welcon Hue-Vu Urinary Drainage BagKNX · Traditional | Welcon, Inc. | 07/29/1997SE |
| K964690 | Liberty ValveKNX · Traditional | Cleveland Medical Devices, Inc. | 03/21/1997SE |
| K964745 | Amsino Urinary Drainage BagKNX · Traditional | Amsino Intl., Inc. | 03/18/1997SE |
| K962652 | Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)KNX · Traditional | Customed, Inc. | 10/04/1996SE |
| K960949 | Prosys Bedside Drainage Bag (Sterile) Model 650167KNX · Traditional | Bristol-Myers Squibb | 04/19/1996SE |
More from Bristol-Myers Squibb
| 510(k) | Device | Decision |
|---|---|---|
| K974190 | Cp&S Instant Cold Pack Limb Kit TransporterIMD · Traditional | 11/19/1997SE |
| K930759 | CP & S Sterile Burn SheetFPY · Traditional | 01/21/1994SE |
| K890550 | Cp&S Disposable Urinary Legbag (Medium & Large)KNX · Traditional | 02/28/1989SE |
| K890552 | Cp&S Gavage Constainer, DisposableKNT · Traditional | 02/24/1989SE |
| K890554 | Cp&S Disposable Instant Super Hot CompressIMD · Traditional | 02/13/1989SE |
| K890553 | Cp&S Disposable Instant Cold CompressIMD · Traditional | 02/13/1989SE |
Questions and answers
When was Urinary Drainage Unit cleared by the FDA?
Urinary Drainage Unit (K890551) received a 510(k) decision of Substantially Equivalent on February 28, 1989, 22 days after the submission was received.
What is the product code of K890551?
The FDA product code is KNX – Collector, Urine, (And Accessories) For Indwelling Catheter, a Class II (moderate risk) device regulated under 21 CFR 876.5250.