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 3 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K030633 | MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT | Medtronic Ave, Inc. | 2003-09-02 | Traditional | PDF ↗ |
| K032360 | MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT | Boston Scientific Corp | 2003-08-27 | Special | PDF ↗ |
| K031331 | WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM | Abbott Vascular, Inc. | 2003-08-12 | Traditional | PDF ↗ |
| K032206 | PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION | Ev3, Inc. | 2003-08-08 | Special | PDF ↗ |
| K031821 | MODIFICATION TO COOK ZILVER BILIARY STENT | Cook, Inc. | 2003-07-18 | Special | PDF ↗ |
| K030638 | DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML | Avantec Vascular Corp. | 2003-07-09 | Traditional | PDF ↗ |
| K031777 | MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 2003-07-07 | Special | PDF ↗ |
| K024303 | EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM | Edwards Lifesciences, LLC | 2003-07-03 | Traditional | PDF ↗ |
| K023666 | RUSCH GUIDED CHOLANGIOGRAPHY CATHETER | Rusch Intl. | 2003-06-17 | Traditional | PDF ↗ |
| K031197 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 2003-06-16 | Special | PDF ↗ |
| K030839 | MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA) | Medtronic Ave, Inc. | 2003-05-30 | Special | PDF ↗ |
| K031186 | LUMINEXX ENDOSCOPIC BILIARY STENT | C.R. Bard, Inc. | 2003-05-06 | Special | PDF ↗ |
| K021672 | PANCREATIC DRAINAGE TUBE | Aomori Olympus Co., Ltd. | 2003-04-16 | Traditional | PDF ↗ |
| K023308 | LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS | Orbus Medical Technologies | 2003-04-14 | Traditional | PDF ↗ |
| K030053 | JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810 | Jomed AG | 2003-03-31 | Traditional | PDF ↗ |
| K030645 | BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT | Boston Scientific Corp | 2003-03-25 | Special | PDF ↗ |
| K030107 | 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM | Boston Scientific Corp | 2003-03-21 | Special | PDF ↗ |
| K030409 | SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM | Cordis Corp. | 2003-03-10 | Special | PDF ↗ |
| K023121 | LIFESTENT BILIARY ENDOPROSTHESIS | Orbus Medical Technologies | 2003-03-10 | Traditional | PDF ↗ |
| K023248 | LIFESTENT LP SDS BILIARY ENDOPROSTHESIS | Orbus Medical Technologies | 2003-02-11 | Traditional | PDF ↗ |
| K010714 | EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830 | Medi-Globe Corp. | 2003-01-21 | Traditional | PDF ↗ |
| K024048 | MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM | Boston Scientific Scimed, Inc. | 2003-01-06 | Special | PDF ↗ |
| K021994 | BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM | C.R. Bard, Inc. | 2003-01-02 | Abbreviated | PDF ↗ |
| K023870 | FLEXIMA BILIARY CATHETER | Boston Scientific/Medi-Tech | 2002-12-20 | Special | PDF ↗ |
| K014215 | VIABIL BILIARY ENDOPROSTHESIS | W. L. Gore & Associates, Inc. | 2002-12-19 | Traditional | PDF ↗ |
| K023243 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Sulzer Intratherapeutics, Inc. | 2002-12-13 | Special | PDF ↗ |
| K021630 | BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM | Boston Scientific Corp | 2002-10-25 | Traditional | PDF ↗ |
| K023217 | MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 2002-10-25 | Special | PDF ↗ |
| K021898 | SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 2002-08-14 | Special | PDF ↗ |
| K022026 | MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS) | Medtronic Ave, Inc. | 2002-07-19 | Special | PDF ↗ |
| K021824 | DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010 | Guidant Corp. | 2002-07-02 | Special | PDF ↗ |
| K021345 | MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM | Cordis Corp. | 2002-06-28 | Special | PDF ↗ |
| K021729 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Sulzer Intratherapeutics, Inc. | 2002-06-21 | Special | PDF ↗ |
| K020788 | WILSON-COOK ZILVER BILIARY STENT | Wilson-Cook Medical, Inc. | 2002-05-08 | Special | PDF ↗ |
| K020528 | INTRASTENT LD (LARGE DIAMETER) STENT | Sulzer Intratherapeutics, Inc. | 2002-04-16 | Special | PDF ↗ |
| K020809 | MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT | Cordis Corp. | 2002-04-12 | Special | PDF ↗ |
| K020682 | BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM | C.R. Bard, Inc. | 2002-04-02 | Special | PDF ↗ |
| K013737 | MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON | Telemed Systems, Inc. | 2002-03-01 | Special | PDF ↗ |
| K020052 | SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 2002-02-11 | Special | PDF ↗ |
| K010549 | BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS) | Medi-Globe Corp. | 2002-01-18 | Traditional | PDF ↗ |
| K014184 | MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM | Guidant Corp. | 2002-01-18 | Special | PDF ↗ |
| K014136 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Sulzer Intratherapeutics, Inc. | 2002-01-17 | Special | PDF ↗ |
| K014205 | MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE) | Medtronic Ave, Inc. | 2002-01-14 | Special | PDF ↗ |
| K014007 | DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM | Guidant Corp. | 2002-01-07 | Special | PDF ↗ |
| K011909 | ULTRA-THIN SDS BALLOON DILATATION CATHETER | Boston Scientific Corp | 2001-11-28 | Traditional | PDF ↗ |
| K010601 | FANELLI BILIARY STENT | Cook, Inc. | 2001-11-16 | Traditional | PDF ↗ |
| K012752 | WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE | Boston Scientific Corp | 2001-11-15 | Traditional | PDF ↗ |
| K012822 | MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX | Boston Scientific Scimed, Inc. | 2001-10-24 | Special | PDF ↗ |
| K011080 | BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM | Medtronic Ave, Inc. | 2001-10-11 | Traditional | PDF ↗ |
| K012993 | MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 2001-10-05 | Special | PDF ↗ |
| K012590 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM | Cordis Corp. | 2001-09-07 | Special | PDF ↗ |
| K011806 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Sulzer Intratherapeutics, Inc. | 2001-09-07 | Traditional | PDF ↗ |
| K010411 | PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM | Cordis Corp. | 2001-08-27 | Abbreviated | PDF ↗ |
| K012347 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Sulzer Intratherapeutics, Inc. | 2001-08-23 | Special | PDF ↗ |
| K011817 | BRIDGE FX | Medtronic Ave, Inc. | 2001-08-22 | Special | PDF ↗ |
| K012216 | NIROYAL BILIARY PREMOUNTED STENT SYSTEM | Boston Scientific Scimed, Inc. | 2001-08-17 | Special | PDF ↗ |
| K010242 | COOK ZILVER BILIARY STENT | Cook, Inc. | 2001-08-13 | Traditional | PDF ↗ |
| K011184 | INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS | Intratherapeutics, Inc. | 2001-08-13 | Special | PDF ↗ |
| K012090 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT | Cordis, A Johnson & Johnson Co. | 2001-08-01 | Special | PDF ↗ |
| K012056 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM | Cordis Europa, N.V. | 2001-08-01 | Special | PDF ↗ |
| K012066 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Sulzer Intratherapeutics, Inc. | 2001-08-01 | Special | PDF ↗ |
| K012087 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT | Cordis Corp. | 2001-08-01 | Special | PDF ↗ |
| K010107 | R STENT BILIARY ENDOPROSTHESIS | Orbus Medical Technologies | 2001-07-31 | Traditional | PDF ↗ |
| K011881 | DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM | Guidant Corp. | 2001-07-18 | Special | PDF ↗ |
| K011506 | OMNILINK .035 BILIARY STENT SYSTEM | Guidant Corp. | 2001-06-15 | Special | PDF ↗ |
| K011039 | OMNILINK .018 BILIARY STENT SYSTEM | Guidant Corp. | 2001-05-08 | Special | PDF ↗ |
| K010684 | RX HERCULINK PLUS BILIARY STENT SYSTEM | Guidant Corp. | 2001-04-12 | Special | PDF ↗ |
| K003929 | NIROYAL BILIARY PREMOUNTED STENT SYSTEM | Boston Scientific Corp | 2001-03-22 | Traditional | PDF ↗ |
| K010445 | PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM | Cordis Corp. | 2001-03-16 | Special | PDF ↗ |
| K002650 | VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726 | Bentec Medical, Inc. | 2001-02-16 | Traditional | PDF ↗ |
| K003997 | INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS | Intratherapeutics, Inc. | 2001-01-24 | Special | PDF ↗ |
| K002235 | HORIZONS ERCP CANNULA | Horizons Intl. Corp. | 2001-01-23 | Traditional | PDF ↗ |
| K003186 | BARD MEMOTHERM ENDOSCOPIC BILIARY STENT | C.R. Bard, Inc. | 2001-01-09 | Traditional | PDF ↗ |
| K003793 | BARD LUMINEXX BILIARY STENT | C.R. Bard, Inc. | 2001-01-05 | Special | PDF ↗ |
| K003753 | GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE | Uresil Corp. | 2001-01-04 | Special | PDF ↗ |
| K003040 | INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Intratherapeutics, Inc. | 2000-12-28 | Traditional | PDF ↗ |
| K003450 | INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS | Intratherapeutics, Inc. | 2000-12-07 | Special | PDF ↗ |
| K003336 | MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 2000-11-22 | Special | PDF ↗ |
| K003365 | S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) | Cordis Corp. | 2000-11-22 | Special | PDF ↗ |
| K002130 | NIR BILIARY STENT | Medinol, Ltd. | 2000-10-30 | Special | PDF ↗ |
| K002133 | NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER | Boston Scientific Corp | 2000-10-12 | Traditional | PDF ↗ |
| K002143 | DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM | Guidant Corp. | 2000-10-12 | Traditional | PDF ↗ |
| K001338 | MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER | Boston Scientific Corp | 2000-08-30 | Traditional | PDF ↗ |
| K001648 | INTRASTENT DOUBLESTRUT PARAMOUNT | Intratherapeutics, Inc. | 2000-08-28 | Traditional | PDF ↗ |
| K002101 | ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER | AngioDynamics, Inc. | 2000-07-31 | Traditional | PDF ↗ |
| K001843 | S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Cordis Corp. | 2000-07-18 | Special | PDF ↗ |
| K001258 | BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM | Cordis Corp. | 2000-06-27 | Special | PDF ↗ |
| K000744 | MEDTRONIC AVE BRIDGE X3 STENT | Medtronic Ave, Inc. | 2000-06-05 | Traditional | PDF ↗ |
| K000308 | WALLSTENT BILIARY ENDOPROSTHESIS | Boston Scientific Corp | 2000-05-19 | Traditional | PDF ↗ |
| K001224 | RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100 | Guidant Corp. | 2000-05-17 | Special | PDF ↗ |
| K001222 | OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1 | Guidant Corp. | 2000-05-17 | Special | PDF ↗ |
| K000864 | INTRASTENT DOUBLESTRUT XS STENT | Intratherapeutics, Inc. | 2000-04-14 | Special | PDF ↗ |
| K000793 | 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER | Guidant Corp. | 2000-04-12 | Special | PDF ↗ |
| K000564 | CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY | Cordis Corp. | 2000-03-23 | Special | PDF ↗ |
| K993303 | SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER | Boston Scientific Corp | 2000-03-23 | Traditional | PDF ↗ |
| K000550 | OTW MEGALINK SDS BILIARY STENT SYSTEM | Advanced Cardiovascular Systems, Inc. | 2000-03-17 | Special | PDF ↗ |
| K993904 | INTRASTENT DOUBLESTRUT LD | Intratherapeutics, Inc. | 2000-02-01 | Traditional | PDF ↗ |
| K994156 | MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B | Cordis Corp. | 2000-01-07 | Special | PDF ↗ |
| K993892 | DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45 | C.R. Bard, Inc. | 2000-01-06 | Special | PDF ↗ |
| K993392 | BARD MEMOTHERM FLEXX BILIARY STENT | C.R. Bard, Inc. | 2000-01-06 | Abbreviated | PDF ↗ |
Product code FGE · Class II · Gastroenterology, Urology. Data: openFDA.