EZD
- Product code
- EZD
- Device name
- Catheter, Straight
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5130
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 23
- Summaries archived here
- 21 (direct download)
- 510(k) clearances (all years, FDA)
- 86 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (23)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260737 | 2026-08-05 | Convatec | Cure Aqua Ready to Use Hydrophilic Intermittent Cat… | |
| K261658 | 2026-07-17 | Wellspect AB | LoFric Origo Pro Coudé | |
| K262045 | 2026-07-07 | Coloplast A.S. | Luja Soft | |
| K260394 | 2026-06-24 | Hangzhou Jimushi Meditech Co., Ltd. | Hydrophilic coated intermittent nalaton catheter for… | |
| K253295 | 2026-05-18 | Hollister Incorporated | Coude Sleeved IC; Coude Plus Sleeved IC | |
| K260999 | 2026-04-24 | Wellspect AB | LoFric Elle Pro | |
| K252943 | 2026-04-01 | Convatec Limited | GentleCath Air for Men; GentleCath Glide Intermitten… | |
| K260502 | 2026-03-12 | HR Healthcare | Liv Pre-lubricated Intermittent Catheter | |
| K251274 | 2026-01-29 | HR Healthcare | EZ-Protect Hydrophilic Closed System Intermittent Ca… | |
| K251178 | 2026-01-02 | Jamjoom Fullcare Corporation | Ready to use Nelaton Catheter | |
| K251468 | 2025-10-03 | Hollister Incorporated | Sleeved IC 3 Family Sleeved IC 3 SWT (name not final… | |
| K250659 | 2025-09-26 | Wellspect AB | LoFric Origo | |
| K250699 | 2025-07-01 | Convatec | Cure Twist Female 8 Catheter (T8); Cure Twist Female… | |
| K251116 | 2025-06-27 | Coloplast Corp. | Luja Coudé | |
| K243175 | 2025-06-26 | Chengdu Daxan Innovative Medical Tech.… | Disposable Intermittent Catheter (TPU Catheter) | FDA |
| K250270 | 2025-04-17 | Coloplast Corp. | Luja Set | |
| K242049 | 2024-11-26 | Coloplast Corp. | SureCath Set | |
| K241210 | 2024-11-21 | Coloplast Corp. | Luja Coude | |
| K241028 | 2024-07-26 | Coloplast | Luja female (20051); Luja female (20052); Luja femal… | |
| K233524 | 2024-05-03 | Hollister Incorporated | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Fina… | |
| K232665 | 2024-01-25 | Convatec | GentleCath Air for Women (CH10); GentleCath Air for … | |
| K230400 | 2023-11-08 | Convatec, Inc. | Cure Catheter Closed System; Cure Dextra Closed Syst… | |
| K233101 | 2023-10-26 | Coloplast Corp. | Luja Coude (20108 Male CH18 - large packaging) | FDA |
Official FDA classification page: EZD
Classification and pathway per current FDA publications. Data from openFDA (CC0).