EZD — Catheter, Straight Class II
FDA Device Classification
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 |
|---|
| 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 |
| K230400 | convatec | Cure Catheter Closed System; Cure Dextra Closed System | November 8, 2023 |
| K233101 | coloplast | Luja Coude (20108 Male CH18 - large packaging) | October 26, 2023 |
| K230165 | coloplast | Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 M | August 25, 2023 |
| K220722 | well lead medical co | PVC Hydrophilic Urethral Catheter | May 22, 2023 |
| K223756 | dentsply sirona | SimPro Now, GentleCath Hydrophilic | May 4, 2023 |
| K222677 | hangzhou jimushi meditech co | Intermittent nelaton catheter for single use | April 5, 2023 |