Well Lead PVC Hydrophilic Urethral Catheter
FDA 510(k) K133615 · Well Lead Medical Co., Ltd.
510(k) numberK133615
Submission
- Device name
- Well Lead PVC Hydrophilic Urethral Catheter
- Applicant
- Well Lead Medical Co., Ltd.
Apollo Beach, FL, US - Received
- November 25, 2013
- Decision date
- February 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- EZD – Catheter, Straight
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260737 | Cure Aqua Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure…EZD · Traditional | Convatec | 08/05/2026SE |
| K261658 | LoFric Origo Pro CoudéEZD · Special | Wellspect AB | 07/17/2026SE |
| K262045 | Luja SoftEZD · Special | Coloplast A.S. | 07/07/2026SE |
| K260394 | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)EZD · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/24/2026SE |
| K253295 | Coude Sleeved IC; Coude Plus Sleeved ICEZD · Traditional | Hollister Incorporated | 05/18/2026SE |
| K260999 | LoFric Elle ProEZD · Special | Wellspect AB | 04/24/2026SE |
| K252943 | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for WomenEZD · Traditional | Convatec Limited | 04/01/2026SE |
| K260502 | Liv Pre-lubricated Intermittent CatheterEZD · Traditional | HR Healthcare | 03/12/2026SE |
| K251274 | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophilic…EZD · Traditional | HR Healthcare | 01/29/2026SESK |
| K251178 | Ready to use Nelaton CatheterEZD · Traditional | Jamjoom Fullcare Corporation | 01/02/2026SE |
More from Jamjoom Fullcare Corporation
| 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 |
| K220036 | Wellead Ureteral CatheterKOD · Traditional | 12/16/2022SE |
| 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 |
Questions and answers
When was Well Lead PVC Hydrophilic Urethral Catheter cleared by the FDA?
Well Lead PVC Hydrophilic Urethral Catheter (K133615) received a 510(k) decision of Substantially Equivalent on February 24, 2014, 91 days after the submission was received.
What is the product code of K133615?
The FDA product code is EZD – Catheter, Straight, a Class II (moderate risk) device regulated under 21 CFR 876.5130.