EZN · Dilator, Catheter, Ureteral
Gastroenterology, Urology · 21 CFR 876.5470 · Class 2
Overview
| Product Code | EZN |
|---|---|
| Device Name | Dilator, Catheter, Ureteral |
| Regulation | 21 CFR 876.5470 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 56)
Showing 20 most recent of 56 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. | May 22, 2025 | SESE |
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter | Allwin Medical Devices, Inc. | May 5, 2023 | SESE |
| K201007 | In-Ka Ureteral Balloon Dilatation Catheter | Coloplast Corp. | Jun 11, 2020 | SESK |
| K190612 | EQUINOX Balloon Dilatation Catheter | Dornier Medtech America, Inc. | Dec 6, 2019 | SESE |
| K173654 | Ureteral Dilator Sets, Ureteral Dilators | Cook Incorporated | Jul 17, 2018 | SESE |
| K180756 | Safety Wire Guide Introducer | Cook Incorporated | May 24, 2018 | SESE |
| K180028 | Cook 810 Set, Desilets-Hoffman Introducer Set | Cook Incorporated | May 2, 2018 | SESE |
| K172588 | Balloon Catheter and Balloon Ureteral Dilator Set | Cook Incorporated | Apr 19, 2018 | SESK |
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators | Coloplast Corp. | Aug 17, 2017 | SESE |
| K132181 | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER | Olympus Surgical Technologies America | Oct 21, 2013 | SESE |
| K130804 | UROMAX ULTRA BALLOON DILATATION CATHETER | Boston Scientific Corporation | May 22, 2013 | SESE |
| K061009 | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS | Onset Medical Corporation | May 2, 2006 | SESE |
| K050875 | U-BALLOON DILATION CATHETER | C.R. Bard, Inc. | May 26, 2005 | SESE |
| K043254 | PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH | Onset Medical Corporation | Feb 10, 2005 | SESE |
| K040127 | COOK URETERAL BALLOON DILATION CATHETER SET | Cook Urological, Inc. | Apr 6, 2004 | SESK |
| K030662 | PATHWAY ACCESS SHEATH CATHETER | Vertelink Corporation | Sep 3, 2003 | SESE |
| K993840 | BARD UROFORCE BALLOON DILATION CATHETER | C.R. Bard, Inc. | Jan 31, 2000 | SESE |
| K990072 | BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C | Cook Urological, Inc. | Mar 25, 1999 | SESE |
| K980795 | UROLOGICAL BALLOON DILATATION CATHETER | Boston Scientific Corp | Apr 22, 1998 | SESE |
| K970041 | ASCEND BALLOON DAILATION CATHETER | Cook Urological, Inc. | Mar 19, 1997 | SESE |
Top Applicants
- Boston Scientific Corp — 8 clearances
- American Edwards Laboratories — 5 clearances
- Cook Urological, Inc. — 5 clearances
- Cook Incorporated — 4 clearances
- Van-Tec, Inc. — 4 clearances
