Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)
FDA 510(k) K170233 · Zhanjiang Star Enterprise Co., Ltd.
510(k) numberK170233
Submission
- Device name
- Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter)
- Applicant
- Zhanjiang Star Enterprise Co., Ltd.
Zhanjiang, CN - Received
- January 25, 2017
- Decision date
- October 13, 2017
- 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 |
|---|---|---|
| K170234 | Endotracheal tube; Reinforced Endotracheal tubeBTR · Traditional | 01/17/2018SE |
Questions and answers
When was Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) cleared by the FDA?
Diposable Urinary Catheter (PVC Urinary Catheter, Silicone Urinary Catheter, Latex Urinary Catheter) (K170233) received a 510(k) decision of Substantially Equivalent on October 13, 2017, 261 days after the submission was received.
What is the product code of K170233?
The FDA product code is EZD – Catheter, Straight, a Class II (moderate risk) device regulated under 21 CFR 876.5130.