Urine Collector Leg Bag
FDA 510(k) K896688 · Medline Industries, Inc.
510(k) numberK896688
Submission
- Device name
- Urine Collector Leg Bag
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- November 28, 1989
- Decision date
- May 2, 1990
- 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
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| K971764 | Welcon Hue-Vu Urinary Drainage BagKNX · Traditional | Welcon, Inc. | 07/29/1997SE |
| K964690 | Liberty ValveKNX · Traditional | Cleveland Medical Devices, Inc. | 03/21/1997SE |
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| K960949 | Prosys Bedside Drainage Bag (Sterile) Model 650167KNX · Traditional | Bristol-Myers Squibb | 04/19/1996SE |
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Questions and answers
When was Urine Collector Leg Bag cleared by the FDA?
Urine Collector Leg Bag (K896688) received a 510(k) decision of Substantially Equivalent on May 2, 1990, 155 days after the submission was received.
What is the product code of K896688?
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.