Mediflex Drainage Bag
FDA 510(k) K843126 · Mediflex Intl.
510(k) numberK843126
Submission
- Device name
- Mediflex Drainage Bag
- Applicant
- Mediflex Intl.
Mchenry, IL, US - Received
- August 10, 1984
- Decision date
- October 4, 1984
- 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 |
|---|---|---|
| K915140 | Primary Dressing TrayLYY · Traditional | 02/11/1992SEKD |
| K900841 | Hemodialysis Transducer ProtectorFIB · Traditional | 05/15/1990SE |
| K891077 | Mediverse Parenteral Nutrition BagKPE · Traditional | 05/24/1989SE |
| K884243 | Blood Tubing SetFJK · Traditional | 12/08/1988SE |
| K863496 | Mediflex Transducer ProtectorFIB · Traditional | 09/23/1986SE |
| K855039 | Mediflex Injection CapGCE · Traditional | 01/24/1986SE |
| K854346 | Mediflex Disposable Tubing ClampFPA · Traditional | 11/18/1985SE |
| K852106 | I.V. Administration SetFPA · Traditional | 06/07/1985SE |
Questions and answers
When was Mediflex Drainage Bag cleared by the FDA?
Mediflex Drainage Bag (K843126) received a 510(k) decision of Substantially Equivalent on October 4, 1984, 55 days after the submission was received.
What is the product code of K843126?
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.