Disposable Urinary Legbag W/Strap
FDA 510(k) K821168 · Medical Marketing Group
510(k) numberK821168
Submission
- Device name
- Disposable Urinary Legbag W/Strap
- Applicant
- Medical Marketing Group
Decatur, GA, US - Received
- April 27, 1982
- Decision date
- May 24, 1982
- 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 |
|---|---|---|
| K910022 | Mmg/O'Neil Urinary Catheterization System KitFCM · Traditional | 04/02/1991SEKD |
| K884819 | O'Neil Urinary Catheter IntroducerKNY · Traditional | 02/17/1989SE |
| K874682 | MMG Catheter Plug W/Drainage Tube CoverKOD · Traditional | 01/27/1988SE |
| K871999 | MMG Uro-Self CatheterGBM · Traditional | 08/25/1987SE |
| K863912 | The MMG 5 in 1 ConnectorBYX · Traditional | 10/27/1986SE |
| K840838 | MMG Connective TubingGAZ · Traditional | 03/30/1984SE |
| K811469 | MMG Urinary Drainage TubingKNX · Traditional | 06/12/1981SE |
| K800694 | MMG Disposable Urinary Leg BagKNX · Traditional | 05/30/1980SE |
| K791847 | Aspri-LukeBYZ · Traditional | 10/02/1979SE |
| K790279 | Catheter, MMG Latex ExternalKNX · Traditional | 03/06/1979SE |
Questions and answers
When was Disposable Urinary Legbag W/Strap cleared by the FDA?
Disposable Urinary Legbag W/Strap (K821168) received a 510(k) decision of Substantially Equivalent on May 24, 1982, 27 days after the submission was received.
What is the product code of K821168?
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.