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 |
|---|---|---|---|
| Nov 4, 1986 | K863571 | BILIARY BALLOON CATHETER Uresil Corp. | FGE |
| Nov 4, 1986 | K862059 | SHEATH, ENDOSCOPE Endovations | FGE |
| Oct 29, 1986 | K863437 | BARD BALLOON DILATATION SYSTEM C.R. Bard, Inc. | FGE |
| Oct 24, 1986 | K863957 | TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU Cathaid, Inc. | FGE |
| May 19, 1986 | K861220 | LUNDERQUIST - RING PTC DRAINAGE CATHETER Meadox Surgimed, Inc. | FGE |
| May 13, 1986 | K860990 | ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY Endovations | FGE |
| Mar 11, 1986 | K855142 | ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY Angiomed U.S., Inc. | FGE |
| Dec 17, 1985 | K851962 | ZIMMON BILIARY STENT SET Wilson-Cook Medical, Inc. | FGE |
| Dec 17, 1985 | K851954 | PVL-4.8-200 BALLOON STONE EXTRACTOR Wilson-Cook Medical, Inc. | FGE |
| Nov 5, 1985 | K853666 | ENDODYNAMICS SIEGEL THERAPUTIC STENT E-Z-Em, Inc. | FGE |
| Oct 4, 1985 | K852293 | BARD-PARKER BILIARY BALLOON CATHETER Bd Becton Dickinson Vacutainer Systems Preanalytic | FGE |
| Sep 20, 1985 | K853543 | DAVOL RETRIEVAL BALLOON CATHETER C.R. Bard, Inc. | FGE |
| Sep 11, 1985 | K851242 | GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO Cook, Inc. | FGE |
| Jul 29, 1985 | K851960 | SOEHENDRA BILIARY DILATING CATHETER-SBDC-7 Wilson-Cook Medical, Inc. | FGE |
| Jul 3, 1985 | K851647 | OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO Meadox Surgimed, Inc. | FGE |
| Jun 13, 1985 | K851956 | VPDS-1 VENNES PANCREATIC DILATION SET Wilson-Cook Medical, Inc. | FGE |
| Feb 14, 1985 | K844384 | BILIARY STENT PROSTHESIS Mentor Corp. | FGE |
| Oct 2, 1984 | K842147 | CATH-TECH CHOLANGIOGRAPHY CATHETER Catheter Technology Corp. | FGE |
| May 22, 1984 | K834413 | DILATION BALLOON CATHETER Hobbs Medical, Inc. | FGE |
| Apr 20, 1984 | K834468 | DRAINAGE STENT Microvasive | FGE |
| Apr 5, 1984 | K834574 | USCI ENDOPROSTHESIS C.R. Bard, Inc. | FGE |
| Mar 22, 1984 | K834351 | BILIARY INDWELLING STENT Hobbs Medical, Inc. | FGE |
| Jan 3, 1984 | K833937 | UMI PERCUTANEOUS TRANSHEPATIC CHOLAN Universal Medical Instrument Corp. | FGE |
| Dec 27, 1983 | K833920 | KELLY CHOLANGIOCATH Perry, Div. | FGE |
| Mar 9, 1983 | K830483 | COONS SOFT STENT Medi-Tech, Inc. | FGE |
| Jan 18, 1983 | K823428 | KELLY INFLATABLE T DRAIN Akron Catheter, Inc. | FGE |
| Aug 20, 1982 | K821819 | PIGTAIL STENTS American Endoscopy, Inc. | FGE |
| Aug 10, 1982 | K821817 | PIGTAIL NASAL CATHETERS American Endoscopy, Inc. | FGE |
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