EZD — Catheter, Straight Class II
FDA product code EZD covers "Catheter, Straight", a Class II medical device regulated under 21 CFR 876.5130. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EZD
- Device Class
- Class II
- Regulation Number
- 876.5130
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261658 | wellspect | LoFric Origo Pro Coudé | July 17, 2026 |
| K262045 | coloplast a.s | Luja Soft | July 7, 2026 |
| K260394 | hangzhou jimushi meditech co | Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NC | June 24, 2026 |
| K253295 | hollister incorporated | Coude Sleeved IC; Coude Plus Sleeved IC | May 18, 2026 |
| K260999 | wellspect | LoFric Elle Pro | April 24, 2026 |
| K252943 | convatec limited | GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air f | April 1, 2026 |
| K260502 | hr healthcare | Liv Pre-lubricated Intermittent Catheter | March 12, 2026 |
| K251274 | hr healthcare | EZ-Protect Hydrophilic Closed System Intermittent Catheter; EZ-Protect Hydrophil | January 29, 2026 |
| K251178 | jamjoom fullcare corporation | Ready to use Nelaton Catheter | January 2, 2026 |
| K251468 | hollister incorporated | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (n | October 3, 2025 |
| K250659 | wellspect | LoFric Origo | September 26, 2025 |
| K250699 | convatec | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twi | July 1, 2025 |
| K251116 | coloplast | Luja Coudé | June 27, 2025 |
| K243175 | chengdu daxan innovative medical tech. co | Disposable Intermittent Catheter (TPU Catheter) | June 26, 2025 |
| K250270 | coloplast | Luja Set | April 17, 2025 |
| K242049 | coloplast | SureCath Set | November 26, 2024 |
| K241210 | coloplast | Luja Coude | November 21, 2024 |
| K241028 | coloplast | Luja female (20051); Luja female (20052); Luja female (20054); Luja female (2005 | July 26, 2024 |
| K233524 | hollister incorporated | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (N | May 3, 2024 |
| K232665 | convatec | GentleCath Air for Women (CH10); GentleCath Air for Women (CH12); GentleCath Air | January 25, 2024 |