Panels › Gastroenterology, Urology › Product code FGE · Class 2
Stents, Drains And Dilators For The Biliary Ducts
Regulation 876.5010
10510(k)s in 12 months (478 all time)
12recalls in 12 months (452 all time)
439recalls that name a 510(k)
Top companies in FGE
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific | 56 | 81 |
| Ev3 Corporation | 12 | 71 |
| Bard Peripheral Vascular, Inc. | 2 | 69 |
| Edwards Lifesciences, LLC | 7 | 52 |
| Cordis Corp. | 38 | 14 |
| Cook Medical Incorporated | 0 | 39 |
| Cook Incorporated | 22 | 13 |
| Wilson-Cook Medical, Inc. | 20 | 15 |
| Hobbs Medical, Inc. | 3 | 21 |
| Guidant Corp. | 20 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 25, 1997 | K970052 | EXTRACTORRX Boston Scientific Corp | FGE |
| Dec 12, 1996 | K963691 | COURIER BALLOON DILATATION CATHETER Boston Scientific Corp | FGE |
| Nov 25, 1996 | K963397 | ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER Boston Scientific Corp | FGE |
| Nov 7, 1996 | K955110 | NAVARRE PERCUTANEOUS BILIARY DRAINAGE Navarre Biomedical , Ltd. | FGE |
| Oct 25, 1996 | K962925 | OLYMPUS B-5/B-7 SERIESBALLOON CATHETER Olympus America, Inc. | FGE |
| Jul 24, 1996 | K954713 | DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) Ideas For Medicine, Inc. | FGE |
| May 23, 1996 | K961216 | MANAN INTRODUCER SHEALTH/NEEDLE Manan Medical Products, Inc. | FGE |
| May 10, 1996 | K961262 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS Boston Scientific Scimed, Inc. | FGE |
| May 10, 1996 | K955126 | LMI BILIARY CATHETER Lucas Medical, Inc. | FGE |
| May 8, 1996 | K955728 | CORDIS BILIARY STENT Cordis Corp. | FGE |
| Mar 26, 1996 | K954043 | MANAN BILIARY DRAINAGE CATHETER Manan Medical Products, Inc. | FGE |
| Feb 8, 1996 | K955413 | ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER Endovations | FGE |
| Oct 7, 1995 | K953332 | MS CLASSIQUE BALLOON DILATATION CAHTETER Meadox Medicals, Div. Boston Scientific Corp. | FGE |
| Sep 12, 1995 | K945498 | INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS Instent, Inc. | FGE |
| Sep 8, 1995 | K924387 | INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS Instent, Inc. | FGE |
| Sep 1, 1995 | K953827 | GIP/MEDI-GLOBE ERCP CATHETERS Medi-Globe Corp. | FGE |
| Jun 30, 1995 | K941973 | GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES Medi-Globe Corp. | FGE |
| Jun 13, 1995 | K944912 | OLYMPUS NBD TUBES Olympus America, Inc. | FGE |
| Apr 5, 1995 | K933200 | OLYMPUS PBD STENTS Olympus Corp. | FGE |
| Mar 13, 1995 | K944143 | MS CLASSIQUE BALLOON CATHETER Meadox Surgimed, Inc. | FGE |
| Mar 9, 1995 | K941350 | WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER Wilson-Cook Medical, Inc. | FGE |
| Feb 28, 1995 | K943143 | BILIARY STENT Menlo Care, Inc. | FGE |
| Jan 24, 1995 | K935094 | BALLOON DILATION CATHETER Wilson-Cook Medical, Inc. | FGE |
| Jan 11, 1995 | K925406 | BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM Schneider Intl., Ltd. | FGE |
| Sep 30, 1994 | K923993 | WALLSTENT BILIARY ENDOPROTHESES Schneider U.S. Stent Div. | FGE |
| Sep 28, 1994 | K930623 | MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH Boston Scientific Corp | FGE |
| Aug 17, 1994 | K940370 | AMERICAN CATHETER E.R.C.P. CANNULA Intl. Medical, Inc. | FGE |
| May 20, 1994 | K940965 | ELIMINATOR BALLOON DILATOR C.R. Bard, Inc. | FGE |
| Feb 7, 1994 | K934377 | INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D. Interventional Thermodynamics, Inc. | FGE |
| Jan 26, 1994 | K924608 | HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS Boston Scientific Corp | FGE |
| Sep 28, 1993 | K931025 | INTHERM STASIS VALVE SYSTEM Interventional Therapeutics Corp. | FGE |
| Jul 13, 1993 | K923096 | URESIL BILLIARY CATHETER Uresil Corp. | FGE |
| Dec 30, 1992 | K924107 | ERCP CANNULA United States Endoscopy Group, Inc. | FGE |
| Nov 24, 1992 | K920361 | BARD BILIARY BALLOON DILATORS C.R. Bard, Inc. | FGE |
| Oct 23, 1992 | K924451 | INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR Interventional Therapeutics Corp. | FGE |
| Jul 2, 1992 | K921654 | MCLEAN-STOCK PERCUTANEOUS T-TUBE SET Cook, Inc. | FGE |
| May 15, 1992 | K921191 | GIANTURCO-ROSCH BILIARY Z STENT Cook, Inc. | FGE |
| May 6, 1992 | K920236 | CHOLANGIOGRAM CATHETER KIT Mccol Medical,Inc. | FGE |
| Mar 11, 1992 | K915813 | ACKRAD ERCP CONTRAST DELIVERY SET Ackrad Laboratories | FGE |
| Feb 19, 1992 | K914699 | URESIL FIXATION DEVICE Uresil Corp. | FGE |
| Jan 30, 1992 | K914495 | E.R.C.P. CATHETER Surgitek Medical Engineering Corp. | FGE |
| Jan 28, 1992 | K913986 | CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM Medical Dynamics, Inc. | FGE |
| Jan 7, 1992 | K914882 | WILTEK BALLOON CHOLANGIOGRAPHY CATHETER Wiltek Medical, Inc. | FGE |
| Jan 7, 1992 | K914881 | WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER Wiltek Medical, Inc. | FGE |
| Nov 29, 1991 | K914277 | WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY Schneider U.S. Stent Div. | FGE |
| Nov 22, 1991 | K913932 | PERCUTANEOUS DILATOR WITH SHEATH Interventional Therapeutics Corp. | FGE |
| Oct 25, 1991 | K913073 | DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT Biosearch Medical Products, Inc. | FGE |
| Oct 8, 1991 | K913841 | 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH Endovations | FGE |
| Sep 27, 1991 | K911630 | LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON Baxter Healthcare Corp | FGE |
| Sep 23, 1991 | K912288 | WILTEK STANDARD CHOLANGIOGRAPHY CATHETER Wiltek Medical, Inc. | FGE |
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