Wellead Ureteral Catheter
FDA 510(k) K220036 · Well Lead Medical Co., Ltd.
510(k) numberK220036
Submission
- Device name
- Wellead Ureteral Catheter
- Applicant
- Well Lead Medical Co., Ltd.
Guangzhou, CN - Received
- January 5, 2022
- Decision date
- December 16, 2022
- 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
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 |
| 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 |
| K171662 | Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End…KOD · Traditional | Cook Incorporated | 02/01/2018SE |
More from Cook Incorporated
| 510(k) | Device | Decision |
|---|---|---|
| K241734 | Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic…GBM · Traditional | 03/05/2025SE |
| K220722 | PVC Hydrophilic Urethral CatheterEZD · Traditional | 05/22/2023SE |
| K211543 | Wei Nasal Jet TubeBTR · Traditional | 07/21/2022SE |
| K211814 | Wellead Endoscopic SealODC · Traditional | 01/14/2022SE |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature SensorEZL · Special | 04/08/2021SE |
| K203119 | ClearPetra Suction-Evacuation SheathFED · Special | 12/09/2020SE |
| K182739 | Endotracheal Tube with Evacuation LumenBTR · Special | 12/11/2019SE |
| K162340 | Stomach TubeKNT · Traditional | 10/11/2017SE |
| K160801 | Well Lead Extraction BagGCJ · Traditional | 11/29/2016SE |
| K161110 | ClearPetra Suction-Evacuation SheathFED · Traditional | 10/12/2016SE |
Questions and answers
When was Wellead Ureteral Catheter cleared by the FDA?
Wellead Ureteral Catheter (K220036) received a 510(k) decision of Substantially Equivalent on December 16, 2022, 345 days after the submission was received.
What is the product code of K220036?
The FDA product code is KOD – Catheter, Urological, a Class II (moderate risk) device regulated under 21 CFR 876.5130.