Rubber Utility Catheter
FDA 510(k) K251864 · C.R. Bard, Inc.
510(k) numberK251864
Submission
- Device name
- Rubber Utility Catheter
- Applicant
- C.R. Bard, Inc.
Covington, GA, US - Received
- June 17, 2025
- Decision date
- February 23, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KOD – Catheter, Urological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
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| K220036 | Wellead Ureteral CatheterKOD · Traditional | Well Lead Medical Co., Ltd. | 12/16/2022SE |
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| 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 |
| K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End…KOD · Traditional | Cook Incorporated | 02/01/2018SE |
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| K252971 | Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser…GEX · Traditional | 03/17/2026SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | 01/31/2025SE |
| K230356 | Aspirex Thrombectomy SystemQEW · Traditional | 03/31/2023SE |
| K223177 | Highlander 014 PTA Balloon Dilatation CatheterLIT · Traditional | 01/20/2023SE |
| K222793 | WavelinQ GeneratorGEI · Special | 10/17/2022SE |
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Questions and answers
When was Rubber Utility Catheter cleared by the FDA?
Rubber Utility Catheter (K251864) received a 510(k) decision of Substantially Equivalent on February 23, 2026, 251 days after the submission was received.
What is the product code of K251864?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.