FDA Product Code
FDA Product Code FGE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5010
510(k) Clearances — 478 records · page 4 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K993232 | WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM | Boston Scientific Scimed, Inc. | 1999-12-30 | Traditional | PDF ↗ |
| K994068 | S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 1999-12-23 | Special | PDF ↗ |
| K993646 | S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 1999-11-28 | Special | PDF ↗ |
| K990808 | PBN DILATORS | Medical Device Technologies, Inc. | 1999-11-26 | Traditional | PDF ↗ |
| K993588 | MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13, | Guidant Corp. | 1999-11-17 | Special | PDF ↗ |
| K993091 | PALMAZ XL TANSHEPATIC BILIARY STENTS | Cordis Corp. | 1999-10-29 | Special | PDF ↗ |
| K993145 | MEDTRONIC AVE BRIDGE STENT | Medtronic Ave, Inc. | 1999-10-21 | Special | PDF ↗ |
| K992816 | MODIFICATION TO INTRASTENT | Intratherapeutics, Inc. | 1999-10-15 | Special | PDF ↗ |
| K992319 | RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM | Guidant Corp. | 1999-10-08 | Traditional | PDF ↗ |
| K992755 | CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE | Cordis, A Johnson & Johnson Co. | 1999-09-15 | Special | PDF ↗ |
| K990867 | RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18 | Advanced Cardiovascular Systems, Inc. | 1999-09-02 | Traditional | PDF ↗ |
| K990592 | INTRASTENT II | Intratherapeutics, Inc. | 1999-09-01 | Traditional | PDF ↗ |
| K992569 | MEDTRONIC AVE BRIDGE STENT | Medtronic Ave, Inc. | 1999-08-31 | Special | PDF ↗ |
| K991674 | CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS | Cordis Corp. | 1999-08-12 | Traditional | PDF ↗ |
| K991028 | CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES | Cordis Corp. | 1999-08-04 | Traditional | PDF ↗ |
| K991929 | INTRASTENT | Intratherapeutics, Inc. | 1999-08-04 | Special | PDF ↗ |
| K990854 | INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE | Innerdyne, Inc. | 1999-08-02 | Traditional | PDF ↗ |
| K992318 | MEDTRONIC AVE BRIDGE STENT | Medtronic Ave, Inc. | 1999-08-02 | Special | PDF ↗ |
| K991533 | MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION | Peripheral Ave | 1999-07-29 | Traditional | PDF ↗ |
| K991793 | ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM | AngioDynamics, Inc. | 1999-06-25 | Special | PDF ↗ |
| K983154 | CYSTIC DUCT BALLOON DILATING CATHETER | Applied Medical Resources | 1999-05-05 | Traditional | PDF ↗ |
| K991032 | GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58 | Guidant Corp. | 1999-04-30 | Special | PDF ↗ |
| K990631 | CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC | Cordis Corp. | 1999-04-30 | Traditional | PDF ↗ |
| K983075 | GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38 | Guidant Corp. | 1999-03-03 | Traditional | PDF ↗ |
| K990130 | WILSON-COOK PANCREATIC WEDGE STENT | Wilson-Cook Medical, Inc. | 1999-02-12 | Special | PDF ↗ |
| K982346 | ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM | AngioDynamics, Inc. | 1999-01-29 | Traditional | PDF ↗ |
| K980823 | CORDIS NITINOL STENT AND DELIVERY SYSTEM | Cordis Corp. | 1998-12-18 | Traditional | PDF ↗ |
| K983008 | PERIPHERAL AVE STENT SYSTEM | Peripheral Ave | 1998-11-25 | Traditional | PDF ↗ |
| K973171 | NIR BILIARY STENT | Medinol, Ltd. | 1998-11-13 | Traditional | PDF ↗ |
| K982508 | FLEXIMA | Boston Scientific Corp | 1998-10-16 | Traditional | PDF ↗ |
| K982005 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1998-09-02 | Traditional | PDF ↗ |
| K980290 | ITI STENT | Intratherapeutics, Inc. | 1998-07-21 | Traditional | PDF ↗ |
| K980653 | PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM | Cordis Corp. | 1998-06-09 | Traditional | PDF ↗ |
| K980372 | MANAN VS ACCESS NEEDLE/SET | Medical Device Technologies, Inc. | 1998-04-27 | Traditional | PDF ↗ |
| K980191 | MANAN BILIARY DRAINAGE CATHETER | Medical Device Technologies, Inc. | 1998-02-09 | Traditional | PDF ↗ |
| K974815 | MANAN(TM) INTRODUCER SHEATH/NEEDLE | Medical Device Technologies, Inc. | 1998-01-09 | Traditional | PDF ↗ |
| K973008 | COURIER ST BALLOON DILATATION CATHETER | Boston Scientific Corp | 1997-12-15 | Traditional | PDF ↗ |
| K972582 | URESIL GUIDEWIRE | Uresil Corp. | 1997-11-21 | Traditional | PDF ↗ |
| K973113 | MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM | Boston Scientific Corp | 1997-11-10 | Traditional | PDF ↗ |
| K971295 | AVE BRIDGE STENT SYSTEM | Arterial Vascular Engineering, Inc. | 1997-11-05 | Traditional | PDF ↗ |
| K972825 | OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB | Cordis Corp. | 1997-10-07 | Traditional | PDF ↗ |
| K973114 | SILICONE BILIARY STENT/BILIARY CATHETER | Specialty Surgical Products, Inc. | 1997-09-19 | Traditional | PDF ↗ |
| K972583 | URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S | Uresil Corp. | 1997-08-29 | Traditional | PDF ↗ |
| K965147 | BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS | Boston Scientific Corp | 1997-06-30 | Traditional | PDF ↗ |
| K964688 | LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT | Cordis Corp. | 1997-06-20 | Traditional | PDF ↗ |
| K963254 | SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Boston Scientific Corp | 1997-05-21 | Traditional | PDF ↗ |
| K962899 | ULTRAFLEX DIAMOND | Boston Scientific Corp | 1997-05-20 | Traditional | PDF ↗ |
| K963767 | MANAN V.S. ACCESS NEEDLE/SET | Manan Medical Products, Inc. | 1997-05-16 | Traditional | PDF ↗ |
| K963782 | BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS | C.R. Bard, Inc. | 1997-05-02 | Traditional | PDF ↗ |
| K964119 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1997-04-28 | Traditional | PDF ↗ |
| K970052 | EXTRACTORRX | Boston Scientific Corp | 1997-03-25 | Traditional | PDF ↗ |
| K963691 | COURIER BALLOON DILATATION CATHETER | Boston Scientific Corp | 1996-12-12 | Traditional | PDF ↗ |
| K963397 | ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER | Boston Scientific Corp | 1996-11-25 | Traditional | PDF ↗ |
| K955110 | NAVARRE PERCUTANEOUS BILIARY DRAINAGE | Navarre Biomedical , Ltd. | 1996-11-07 | Traditional | PDF ↗ |
| K962925 | OLYMPUS B-5/B-7 SERIESBALLOON CATHETER | Olympus America, Inc. | 1996-10-25 | Traditional | PDF ↗ |
| K954713 | DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION) | Ideas For Medicine, Inc. | 1996-07-24 | Traditional | PDF ↗ |
| K961216 | MANAN INTRODUCER SHEALTH/NEEDLE | Manan Medical Products, Inc. | 1996-05-23 | Traditional | PDF ↗ |
| K961262 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1996-05-10 | Traditional | PDF ↗ |
| K955126 | LMI BILIARY CATHETER | Lucas Medical, Inc. | 1996-05-10 | Traditional | PDF ↗ |
| K955728 | CORDIS BILIARY STENT | Cordis Corp. | 1996-05-08 | Traditional | PDF ↗ |
| K954043 | MANAN BILIARY DRAINAGE CATHETER | Manan Medical Products, Inc. | 1996-03-26 | Traditional | PDF ↗ |
| K955413 | ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER | Endovations | 1996-02-08 | Traditional | PDF ↗ |
| K953332 | MS CLASSIQUE BALLOON DILATATION CAHTETER | Meadox Medicals, Div. Boston Scientific Corp. | 1995-10-07 | Traditional | PDF ↗ |
| K945498 | INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS | Instent, Inc. | 1995-09-12 | Traditional | PDF ↗ |
| K924387 | INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS | Instent, Inc. | 1995-09-08 | Traditional | PDF ↗ |
| K953827 | GIP/MEDI-GLOBE ERCP CATHETERS | Medi-Globe Corp. | 1995-09-01 | Traditional | PDF ↗ |
| K941973 | GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES | Medi-Globe Corp. | 1995-06-30 | Traditional | PDF ↗ |
| K944912 | OLYMPUS NBD TUBES | Olympus America, Inc. | 1995-06-13 | Traditional | PDF ↗ |
| K933200 | OLYMPUS PBD STENTS | Olympus Corp. | 1995-04-05 | Traditional | PDF ↗ |
| K944143 | MS CLASSIQUE BALLOON CATHETER | Meadox Surgimed, Inc. | 1995-03-13 | Traditional | PDF ↗ |
| K941350 | WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER | Wilson-Cook Medical, Inc. | 1995-03-09 | Traditional | PDF ↗ |
| K943143 | BILIARY STENT | Menlo Care, Inc. | 1995-02-28 | Traditional | PDF ↗ |
| K935094 | BALLOON DILATION CATHETER | Wilson-Cook Medical, Inc. | 1995-01-24 | Traditional | PDF ↗ |
| K925406 | BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM | Schneider Intl., Ltd. | 1995-01-11 | Traditional | PDF ↗ |
| K923993 | WALLSTENT BILIARY ENDOPROTHESES | Schneider U.S. Stent Div. | 1994-09-30 | Traditional | PDF ↗ |
| K930623 | MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH | Boston Scientific Corp | 1994-09-28 | Traditional | PDF ↗ |
| K940370 | AMERICAN CATHETER E.R.C.P. CANNULA | Intl. Medical, Inc. | 1994-08-17 | Traditional | PDF ↗ |
| K940965 | ELIMINATOR BALLOON DILATOR | C.R. Bard, Inc. | 1994-05-20 | Traditional | PDF ↗ |
| K934377 | INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D. | Interventional Thermodynamics, Inc. | 1994-02-07 | Traditional | PDF ↗ |
| K924608 | HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS | Boston Scientific Corp | 1994-01-26 | Traditional | PDF ↗ |
| K931025 | INTHERM STASIS VALVE SYSTEM | Interventional Therapeutics Corp. | 1993-09-28 | Traditional | PDF ↗ |
| K923096 | URESIL BILLIARY CATHETER | Uresil Corp. | 1993-07-13 | Traditional | PDF ↗ |
| K924107 | ERCP CANNULA | United States Endoscopy Group, Inc. | 1992-12-30 | Traditional | PDF ↗ |
| K920361 | BARD BILIARY BALLOON DILATORS | C.R. Bard, Inc. | 1992-11-24 | Traditional | PDF ↗ |
| K924451 | INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR | Interventional Therapeutics Corp. | 1992-10-23 | Traditional | PDF ↗ |
| K921654 | MCLEAN-STOCK PERCUTANEOUS T-TUBE SET | Cook, Inc. | 1992-07-02 | Traditional | PDF ↗ |
| K921191 | GIANTURCO-ROSCH BILIARY Z STENT | Cook, Inc. | 1992-05-15 | Traditional | PDF ↗ |
| K920236 | CHOLANGIOGRAM CATHETER KIT | Mccol Medical,Inc. | 1992-05-06 | Traditional | PDF ↗ |
| K915813 | ACKRAD ERCP CONTRAST DELIVERY SET | Ackrad Laboratories | 1992-03-11 | Traditional | PDF ↗ |
| K914699 | URESIL FIXATION DEVICE | Uresil Corp. | 1992-02-19 | Traditional | PDF ↗ |
| K914495 | E.R.C.P. CATHETER | Surgitek Medical Engineering Corp. | 1992-01-30 | Traditional | PDF ↗ |
| K913986 | CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM | Medical Dynamics, Inc. | 1992-01-28 | Traditional | PDF ↗ |
| K914881 | WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | Wiltek Medical, Inc. | 1992-01-07 | Traditional | PDF ↗ |
| K914882 | WILTEK BALLOON CHOLANGIOGRAPHY CATHETER | Wiltek Medical, Inc. | 1992-01-07 | Traditional | PDF ↗ |
| K914277 | WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY | Schneider U.S. Stent Div. | 1991-11-29 | Traditional | PDF ↗ |
| K913932 | PERCUTANEOUS DILATOR WITH SHEATH | Interventional Therapeutics Corp. | 1991-11-22 | Traditional | PDF ↗ |
| K913073 | DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT | Biosearch Medical Products, Inc. | 1991-10-25 | Traditional | PDF ↗ |
| K913841 | 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH | Endovations | 1991-10-08 | Traditional | PDF ↗ |
| K911630 | LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON | Baxter Healthcare Corp | 1991-09-27 | Traditional | PDF ↗ |
| K912288 | WILTEK STANDARD CHOLANGIOGRAPHY CATHETER | Wiltek Medical, Inc. | 1991-09-23 | Traditional | PDF ↗ |
Product code FGE · Class II · Gastroenterology, Urology. Data: openFDA.