Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
FDA 510(k) K241734 · Well Lead Medical Co., Ltd.
510(k) numberK241734
Submission
- Device name
- Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact
- Applicant
- Well Lead Medical Co., Ltd.
Guangzhou, CN - Received
- June 17, 2024
- Decision date
- March 5, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GBM – Catheter, Urethral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5130
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GBM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterGBM · Traditional | Convatec Limited | 06/22/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | Hollister Incorporated | 01/27/2022SE |
| K200820 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/13/2020SE |
| K192904 | SpeediCath Compact SetGBM · Traditional | Coloplast | 11/02/2020SE |
| K200142 | SpeediCath SoftGBM · Traditional | Coloplast | 07/30/2020SE |
| K200134 | Jimushi Sterile Urethral Catheter for single useGBM · Traditional | Hangzhou Jimushi Meditech Co., Ltd. | 06/01/2020SE |
| K191512 | LotusCatheter (Lotus No Balloon Catheter)GBM · Traditional | Hakki Medical Technologies, Inc. | 05/21/2020SESK |
| K192577 | Actreen Hi-Lite Intermittent Urinary CathetersGBM · Special | B.Braun Medical, Inc. | 05/07/2020SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | Hollister Incorporated | 12/13/2019SE |
| K192468 | Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use…GBM · Traditional | Hangzhou Bever Medical Devices Co., Ltd. | 11/27/2019SE |
More from Hangzhou Bever Medical Devices Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K161110 | ClearPetra Suction-Evacuation SheathFED · Traditional | 10/12/2016SE |
Questions and answers
When was Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact cleared by the FDA?
Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter Compact (K241734) received a 510(k) decision of Substantially Equivalent on March 5, 2025, 261 days after the submission was received.
What is the product code of K241734?
The FDA product code is GBM – Catheter, Urethral, a Class II (moderate risk) device regulated under 21 CFR 876.5130.