Haematuria Catheters
FDA 510(k) K841511 · Warne Surgical Products, Ltd.
510(k) numberK841511
Submission
- Device name
- Haematuria Catheters
- Applicant
- Warne Surgical Products, Ltd.
Walker, MI, US - Received
- April 11, 1984
- Decision date
- July 12, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KOD – Catheter, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code KOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251864 | Rubber Utility CatheterKOD · Traditional | C.R. Bard, Inc. | 02/23/2026SE |
| K220036 | Wellead Ureteral CatheterKOD · Traditional | Well Lead Medical Co., Ltd. | 12/16/2022SE |
| K220730 | allFlex Ureteral Catheters, Krait Ureteral CathetersKOD · Traditional | Allwin Medical Devices, Inc. | 10/13/2022SE |
| K211032 | Urinary Catheter 12 Fr, Urinary Catheter 16 FrKOD · Traditional | Urogen Pharma, Ltd. | 11/19/2021SE |
| K181979 | Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterKOD · Traditional | Teleflexmedical, Inc. | 05/24/2019SE |
| K180354 | UroGen Ureteral CatheterKOD · Traditional | Urogen Pharma, Ltd. | 10/30/2018SE |
| K181144 | Angled Tip Ureteral CatheterKOD · Traditional | Cook Incorporated | 06/28/2018SE |
| K180530 | Imager II Urology Torque CatheterKOD · Special | Boston Scientific Corporation | 04/10/2018SE |
| K171810 | Cone Tip Ureteral Catheter, Rutner Universal Wedge CatheterKOD · Traditional | Cook Incorporated | 03/07/2018SE |
| K171600 | Renal Access Cobra Catheter, Kumpe Access CatheterKOD · Traditional | Cook Incorporated | 02/16/2018SE |
More from Cook Incorporated
| 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 |
| 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 |
| K840704 | Secure W/35MM Diam, Sheath/AdhesiveKNX · Traditional | 03/22/1984SE |
Questions and answers
When was Haematuria Catheters cleared by the FDA?
Haematuria Catheters (K841511) received a 510(k) decision of Substantially Equivalent on July 12, 1984, 92 days after the submission was received.
What is the product code of K841511?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.