Panels › Gastroenterology, Urology › Product code EZN · Class 2
Dilator, Catheter, Ureteral
Regulation 876.5470
0510(k)s in 12 months (56 all time)
0recalls in 12 months (14 all time)
14recalls that name a 510(k)
Top companies in EZN
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 22, 2025 | K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter Urotronic, Inc. | EZN |
| May 5, 2023 | K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator Allwin Medical Devices, Inc. | EZN |
| Jun 11, 2020 | K201007 | In-Ka Ureteral Balloon Dilatation Catheter Coloplast Corp. | EZN |
| Dec 6, 2019 | K190612 | EQUINOX Balloon Dilatation Catheter Dornier Medtech America, Inc. | EZN |
| Jul 17, 2018 | K173654 | Ureteral Dilator Sets, Ureteral Dilators Cook Incorporated | EZN |
| May 24, 2018 | K180756 | Safety Wire Guide Introducer Cook Incorporated | EZN |
| May 2, 2018 | K180028 | Cook 810 Set, Desilets-Hoffman Introducer Set Cook Incorporated | EZN |
| Apr 19, 2018 | K172588 | Balloon Catheter and Balloon Ureteral Dilator Set Cook Incorporated | EZN |
| Aug 17, 2017 | K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators Coloplast Corp. | EZN |
| Oct 21, 2013 | K132181 | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER Olympus Surgical Technologies America | EZN |
| May 22, 2013 | K130804 | UROMAX ULTRA BALLOON DILATATION CATHETER Boston Scientific Corporation | EZN |
| May 2, 2006 | K061009 | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS Onset Medical Corporation | EZN |
| May 26, 2005 | K050875 | U-BALLOON DILATION CATHETER C.R. Bard, Inc. | EZN |
| Feb 10, 2005 | K043254 | PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH Onset Medical Corporation | EZN |
| Apr 6, 2004 | K040127 | COOK URETERAL BALLOON DILATION CATHETER SET Cook Urological, Inc. | EZN |
| Sep 3, 2003 | K030662 | PATHWAY ACCESS SHEATH CATHETER Vertelink Corporation | EZN |
| Jan 31, 2000 | K993840 | BARD UROFORCE BALLOON DILATION CATHETER C.R. Bard, Inc. | EZN |
| Mar 25, 1999 | K990072 | BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C Cook Urological, Inc. | EZN |
| Apr 22, 1998 | K980795 | UROLOGICAL BALLOON DILATATION CATHETER Boston Scientific Corp | EZN |
| Mar 19, 1997 | K970041 | ASCEND BALLOON DAILATION CATHETER Cook Urological, Inc. | EZN |
| Oct 9, 1996 | K962921 | BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER C.R. Bard, Inc. | EZN |
| Oct 16, 1995 | K953691 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING Meadox Medicals, Div. Boston Scientific Corp. | EZN |
| Oct 7, 1995 | K953597 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER Meadox Medicals, Div. Boston Scientific Corp. | EZN |
| Sep 13, 1995 | K953004 | DILATATION CATHETER, BALLOON Boston Scientific Corp | EZN |
| Jan 24, 1995 | K945576 | MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) Meadox Medicals, Div. Boston Scientific Corp. | EZN |
| Sep 12, 1994 | K941853 | PASSPORT Boston Scientific Corp | EZN |
| Aug 19, 1994 | K942578 | ENTRAC URETERAL BALLOON DILATATION CATHETERS American Medical Systems, Inc. | EZN |
| Apr 18, 1994 | K940542 | NAMIC ARIA(TM) INFLATION DEVICE American Medical Systems, Inc. | EZN |
| Feb 14, 1994 | K935379 | UROLOGICAL BALLOON DILATATION CATHETER Boston Scientific Corp | EZN |
| Feb 1, 1994 | K933011 | MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER Boston Scientific Corp | EZN |
| Oct 28, 1992 | K921839 | ENTRAC URETERAL BALLOON DILATION CATHETERS American Medical Systems, Inc. | EZN |
| Jul 1, 1992 | K920946 | UROLOGICAL BALLOON DILATATION CATHETER Boston Scientific Corp | EZN |
| Apr 24, 1992 | K915751 | URETEROMAT 4400 F.M. Wiest USA, Inc. | EZN |
| Mar 18, 1992 | K915392 | ACCENT DG BALLOON URTERAL DILATOR SET, 10CM Cook Urological, Inc. | EZN |
| Dec 20, 1991 | K914617 | CATHETER, URETERAL DILATOR Boston Scientific Corp | EZN |
| Oct 30, 1991 | K912331 | URS-HYDRO-DILATOR MODEL NUMBER 2164.00 Richard Wolf Medical Instruments Corp. | EZN |
| Apr 12, 1991 | K905375 | ACCENT DG BALLOON URETERAL DILATOR SET Cook Urological, Inc. | EZN |
| Mar 6, 1991 | K905181 | NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY Meadox Surgimed, Inc. | EZN |
| Jan 30, 1991 | K904983 | MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY Meadox Surgimed, Inc. | EZN |
| Nov 7, 1990 | K903813 | URETERAL BALLOON DILATATION CATHETER Boston Scientific Corp | EZN |
| Mar 7, 1990 | K896448 | BALLOON DILATION CATHETER Cook Ob/Gyn | EZN |
| Dec 13, 1989 | K894925 | AMCATH URETERAL DILATORS MODELS 7100,7110,7120 Intec Medical, Inc. | EZN |
| Sep 29, 1989 | K884711 | URETHRAL AND URETERAL BALLOON DILATATORS Primrose Medical, Inc. | EZN |
| Sep 30, 1987 | K873178 | URETERAL BULB DILATORS Penn Medical Devices, Inc. | EZN |
| Mar 10, 1987 | K870697 | VAN-TEC ONE STEP URETERAL DILATATION CATHETER Van-Tec, Inc. | EZN |
| Aug 21, 1985 | K852324 | URETERAL DILATOR American Edwards Laboratories | EZN |
| Aug 9, 1985 | K852793 | URETERAL DILATOR/SHEATH SET American Edwards Laboratories | EZN |
| May 23, 1985 | K851463 | OLBERT CATHETER SYS FOR URETERAL DILATION Meadox Surgimed, Inc. | EZN |
| Apr 9, 1985 | K851144 | URETERAL DILATION SET Van-Tec, Inc. | EZN |
| Mar 12, 1985 | K850355 | MENTOR PERCUTANEOUS RENAL DILATOR SET Mentor Corp. | EZN |
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