Secure W/35MM Diam, Sheath/Adhesive
FDA 510(k) K840704 · Warne Surgical Products, Ltd.
510(k) numberK840704
Submission
- Device name
- Secure W/35MM Diam, Sheath/Adhesive
- Applicant
- Warne Surgical Products, Ltd.
Mchenry, IL, US - Received
- February 17, 1984
- Decision date
- March 22, 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 |
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| K972887 | Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg BagKNX · Traditional | Medline Industries, Inc. | 12/11/1997SE |
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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 |
| 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 |
|---|---|---|
| K850696 | WSP Code 4300 Diomaster DiagnosticFAP · Traditional | 05/17/1985SE |
| K850694 | WSP Code 4310 StresscathFAP · Traditional | 05/17/1985SE |
| K850695 | WSP Code 4301 Diomaster TherapeuticFAP · Traditional | 05/16/1985SE |
| K850693 | WSP Code 4315 PadtestFAP · Traditional | 05/10/1985SE |
| K841511 | Haematuria CathetersKOD · Traditional | 07/12/1984SE |
| K840687 | Kidney Transplant CatheterKDN · Traditional | 06/07/1984SE |
| K841412 | Rolled Neck W/TapBTC · Traditional | 04/18/1984SE |
| K841411 | Rolled Neck W/PlugBTC · Traditional | 04/18/1984SE |
| K841410 | Bush Neck W/TapDRM · Traditional | 04/18/1984SE |
| K841409 | Bush Neck W/PlugBYZ · Traditional | 04/18/1984SE |
Questions and answers
When was Secure W/35MM Diam, Sheath/Adhesive cleared by the FDA?
Secure W/35MM Diam, Sheath/Adhesive (K840704) received a 510(k) decision of Substantially Equivalent on March 22, 1984, 34 days after the submission was received.
What is the product code of K840704?
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.