| 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 |