Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)
FDA 510(k) K962652 · Customed, Inc.
510(k) numberK962652
Submission
- Device name
- Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)
- Applicant
- Customed, Inc.
Fajardo, PR, US - Received
- July 8, 1996
- Decision date
- October 4, 1996
- 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 |
| 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 |
| 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 |
|---|---|---|
| K260116 | CustoMED ViewerLLZ · Traditional | 06/03/2026SE |
| K974647 | Fanfold Drape 41 X 57 Product No. 900-633, Recorder No. 0633KKX · Traditional | 01/05/1998SE |
| K971920 | Gown Poly Reinforced Large(Product NO.900-522)/(REORDER No. 0522)FYA · Traditional | 12/04/1997SE |
| K964011 | Suction Catheter Tray Product No. 900277LRO · Traditional | 11/25/1996SESK |
| K962596 | Customed Blood Extraction KitGJE · Traditional | 09/27/1996SE |
| K961442 | Universal Drainage TrayFCM · Traditional | 05/09/1996SE |
| K953678 | Sterimed Sterization Wrapper (Non-Sterile)FRG · Traditional | 10/02/1995SE |
| K950295 | Wound Closure/Laceration TrayLRO · Traditional | 04/18/1995SE |
| K942177 | Foley Catheterization TrayFCM · Traditional | 09/08/1994SE |
| K925018 | IV Prep Kit W/O Dressing (Non-Sterile)LRS · Traditional | 08/27/1993SEKD |
Questions and answers
When was Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749) cleared by the FDA?
Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749) (K962652) received a 510(k) decision of Substantially Equivalent on October 4, 1996, 88 days after the submission was received.
What is the product code of K962652?
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.