Amsino Urinary Leg Bag
FDA 510(k) K971929 · Amsino Intl., Inc.
510(k) numberK971929
Submission
- Device name
- Amsino Urinary Leg Bag
- Applicant
- Amsino Intl., Inc.
Pomona, CA, US - Received
- May 27, 1997
- Decision date
- August 6, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| 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 |
|---|---|---|
| K070873 | Amsure Bladder Irrigation SetLJH · Traditional | 12/19/2007SE |
| K992719 | Amsure Enteral Delivery Pump Set with SpikeKNT · Traditional | 01/12/2000SE |
| K974042 | Amsure Cleansing Enema SetFCE · Traditional | 12/19/1997SE |
| K973107 | Amsino I.V. Administration SetFPA · Traditional | 10/02/1997SE |
| K973199 | Amsino Suction CatheterBSY · Traditional | 09/10/1997SE |
| K964745 | Amsino Urinary Drainage BagKNX · Traditional | 03/18/1997SE |
| K950780 | Amsino Cervical ScraperHHT · Traditional | 07/25/1995SE |
| K951528 | Amsino Disposable Viginal SpeculumHIB · Traditional | 05/11/1995SE |
Questions and answers
When was Amsino Urinary Leg Bag cleared by the FDA?
Amsino Urinary Leg Bag (K971929) received a 510(k) decision of Substantially Equivalent on August 6, 1997, 71 days after the submission was received.
What is the product code of K971929?
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.