Welcon Hue-Vu Urinary Drainage Bag
FDA 510(k) K971764 · Welcon, Inc.
510(k) numberK971764
Submission
- Device name
- Welcon Hue-Vu Urinary Drainage Bag
- Applicant
- Welcon, Inc.
Providence, RI, US - Received
- May 13, 1997
- Decision date
- July 29, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K952208 | Prosys Leg BagKNX · Traditional | Convatec, A Division of E.R. Squibb & Sons | 08/15/1995SE |
More from Convatec, A Division of E.R. Squibb & Sons
| 510(k) | Device | Decision |
|---|---|---|
| K003402 | Welcon Sterile Water for Device Irrigation; Welcon Sterile 0.9% Normal Saline for Device…JOL · Traditional | 05/01/2001SE |
| K973734 | Sterile Water for Device Irrigation/ Sterile Saline for Device IrrigationJOL · Traditional | 02/05/1998SE |
| K912869 | Women and Infant's Delivery PackHFW · Traditional | 12/04/1991SE |
| K904158 | Accorde(R) Irrigating Syringe/Procedure TrayFCM · Traditional | 11/29/1990SEKD |
| K894397 | Welcon Light HandleFTA · Traditional | 08/10/1989SE |
| K830359 | Sterile Catherization Procedure TraysKOD · Traditional | 03/17/1983SE |
| K813027 | Sterile Irrigating Syringes, Kits,TrayKYZ · Traditional | 11/20/1981SE |
Questions and answers
When was Welcon Hue-Vu Urinary Drainage Bag cleared by the FDA?
Welcon Hue-Vu Urinary Drainage Bag (K971764) received a 510(k) decision of Substantially Equivalent on July 29, 1997, 77 days after the submission was received.
What is the product code of K971764?
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.