EZN — Dilator, Catheter, Ureteral Class II
FDA product code EZN covers "Dilator, Catheter, Ureteral", a Class II medical device regulated under 21 CFR 876.5470. 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
- EZN
- Device Class
- Class II
- Regulation Number
- 876.5470
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250910 | urotronic | Optilume® High Pressure Urological Balloon Dilation Catheter | May 22, 2025 |
| K220781 | allwin medical devices | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz | May 5, 2023 |
| K201007 | coloplast | In-Ka Ureteral Balloon Dilatation Catheter | June 11, 2020 |
| K190612 | dornier medtech america | EQUINOX Balloon Dilatation Catheter | December 6, 2019 |
| K173654 | cook incorporated | Ureteral Dilator Sets, Ureteral Dilators | July 17, 2018 |
| K180756 | cook incorporated | Safety Wire Guide Introducer | May 24, 2018 |
| K180028 | cook incorporated | Cook 810 Set, Desilets-Hoffman Introducer Set | May 2, 2018 |
| K172588 | cook incorporated | Balloon Catheter and Balloon Ureteral Dilator Set | April 19, 2018 |
| K170531 | coloplast | Ureteral Dilators and Percutaneous Nephrostomy Dilators | August 17, 2017 |
| K132181 | olympus surgical technologies america | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER | October 21, 2013 |
| K130804 | boston scientific corporation | UROMAX ULTRA BALLOON DILATATION CATHETER | May 22, 2013 |
| K061009 | onset medical corporation | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS | May 2, 2006 |
| K050875 | c.r. bard | U-BALLOON DILATION CATHETER | May 26, 2005 |
| K043254 | onset medical corporation | PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH | February 10, 2005 |
| K040127 | cook urological | COOK URETERAL BALLOON DILATION CATHETER SET | April 6, 2004 |
| K030662 | vertelink corporation | PATHWAY ACCESS SHEATH CATHETER | September 3, 2003 |
| K993840 | c.r. bard | BARD UROFORCE BALLOON DILATION CATHETER | January 31, 2000 |
| K990072 | cook urological | BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOO | March 25, 1999 |
| K980795 | boston scientific | UROLOGICAL BALLOON DILATATION CATHETER | April 22, 1998 |
| K970041 | cook urological | ASCEND BALLOON DAILATION CATHETER | March 19, 1997 |