Uro-Male Incontinence Catheter
FDA 510(k) K841224 · Gil-Med Industries C/O Kegan & Kegan, Ltd.
510(k) numberK841224
Submission
- Device name
- Uro-Male Incontinence Catheter
- Applicant
- Gil-Med Industries C/O Kegan & Kegan, Ltd.
Mchenry, IL, US - Received
- March 22, 1984
- Decision date
- May 2, 1984
- 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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| 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 |
| 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 |
More from Bristol-Myers Squibb
| 510(k) | Device | Decision |
|---|---|---|
| K880506 | Modified Eva-Mix and Di-Mix BagsKPE · Traditional | 05/20/1988SE |
| K870274 | Di-Mix Parenteral Nutrition & Medicine ContainerKPE · Traditional | 02/10/1987SE |
| K861862 | Dieto Container for Enteral NutritionKNT · Traditional | 08/11/1986SE |
| K841597 | Gil-Med Parenteral Nutrition or MedicineKPE · Traditional | 10/26/1984SE |
| K840915 | Dimix Container for Parneteral NutritKPE · Traditional | 04/17/1984SE |
| K840916 | Dieto Container for Enternal NutritKNT · Traditional | 04/04/1984SE |
Questions and answers
When was Uro-Male Incontinence Catheter cleared by the FDA?
Uro-Male Incontinence Catheter (K841224) received a 510(k) decision of Substantially Equivalent on May 2, 1984, 41 days after the submission was received.
What is the product code of K841224?
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.