Urethal Catheter
FDA 510(k) K874309 · Medovations, Inc.
510(k) numberK874309
Submission
- Device name
- Urethal Catheter
- Applicant
- Medovations, Inc.
Milwaukee, WI, US - Received
- October 20, 1987
- Decision date
- December 7, 1987
- 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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| K924646 | Over the Guidewire Dilatation SystemKNQ · Traditional | 12/05/1994SE |
| K913678 | Trocar CatheterKGY · Traditional | 12/16/1991SE |
| K905478 | Yankauer Suction DeviceMDM · Traditional | 12/19/1990SE |
| K864963 | Stomach Evaculator - Ewald StyleKOA · Traditional | 10/14/1987SE |
| K864962 | Oberto Mouth PropJXL · Traditional | 02/19/1987SE |
| K864964 | 5 - in - 1 ConnectorGAZ · Traditional | 01/20/1987SE |
| K854616 | Enteral Feeding BagKNT · Traditional | 01/23/1986SE |
Questions and answers
When was Urethal Catheter cleared by the FDA?
Urethal Catheter (K874309) received a 510(k) decision of Substantially Equivalent on December 7, 1987, 48 days after the submission was received.
What is the product code of K874309?
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.