Stents, Drains And Dilators For The Biliary Ducts
FDA product code FGE · 462 cleared devices
Class 2
Gastroenterology, Urology
- Regulation
- 21 CFR 876.5010
- Review panel
- GU
- Implant
- Yes
- Life sustaining
- Yes
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1982-08-10 – 2026-09-18
FGE
2008-08-18
FGE
2008-08-01
MODIFICATION TO ZILVER 635 BILIARY STENT
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FGE
2008-07-22
GORE VIABIL BILILARY ENDOPROSTHESIS
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FGE
2008-05-30
BARD E LUMINEXX BILIARY STENT
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FGE
2008-04-11
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
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FGE
2008-03-18
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
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FGE
2008-02-06
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
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FGE
2008-01-31
SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
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FGE
2008-01-24
SKATER BILIARY CATHETER
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FGE
2007-11-14
RESOLVE BILIARY DRAINAGE CATHETER
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FGE
2007-11-08
COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
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FGE
2007-09-14
MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
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FGE
2007-06-21
SKATER BILIARY CATHETER
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FGE
2006-09-01
WELLFLEX BILIARY RX STENT SYSTEM
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FGE
2006-08-31
PRIMUS GPS BILIARY STENT SYSTEM
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FGE
2006-08-15
SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060
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FGE
2006-08-04
MARATHON STENT WITH FUSION TECHNOLOGY
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FGE
2006-06-15
OMNILINK. 018 BILIARY STENT SYSTEM
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FGE
2006-06-05
LIFESTENT TURBO BILIARY STENT SYSTEM
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FGE
2006-04-27
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
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FGE
2006-04-12
OMNILINK .035 BILIARY STENT SYSTEM
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FGE
2006-03-23
LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
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FGE
2006-03-09
ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
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FGE
2006-03-08
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
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FGE
2006-03-06
RX HERCULINK ELITE BILIARY STENT SYSTEM
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FGE
2005-12-21
LIFESTENT FLEXSTART BILIARY STENT SYSTEM
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FGE
2005-12-20
GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
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FGE
2005-12-09
COOK FORMULA 418 BILIARY STENT SYSTEM
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FGE
2005-08-25
BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
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FGE
2005-08-24
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
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FGE
2005-08-23
FORMULA 418 BILIARY STENT
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FGE
2005-07-12
ZILVER 635 BILIARY STENT
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FGE
2005-07-08
SINGLE USE BALLOON DILATOR MAXPASSTM
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FGE
2005-06-17
PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT
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FGE
2005-05-20
XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
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FGE
2005-04-22
PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
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FGE
2005-04-20
PROTEGE GPS SELF-EXPANDING NITINOL STENT
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FGE
2005-03-30
MODIFICATION TO:ZILVER 518 BILIARY STENT
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FGE
2005-03-22
LIFESTENT TURBO BILIARY STENT SYSTEMS
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FGE
2005-03-14
MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
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FGE
2005-02-16
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
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FGE
2005-02-14
BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
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FGE
2004-12-29
MODIFICATION TO: ZILVER 635 BILIARY STENT
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FGE
2004-12-23
LIFESTENT NT35 BILIARY STENT SYSTEM
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FGE
2004-12-09
PRIMUS STENT AND DELIVERY SYSTEM
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FGE
2004-11-08
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2004-10-01
ZILVER 518 BILIARY STENT
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FGE
2004-10-01
XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
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FGE
2004-08-23
MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT
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FGE
2004-08-03
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2004-07-21
VIABIL BILIARY ENDOPROSTHESIS
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FGE
2004-07-07
EXTRACTOR RX RETRIEVAL BALLOON
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FGE
2004-07-02
ZILVER BILIARY STENT SYSTEM USW
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FGE
2004-06-25
WILOSN-COOK BILIARY DILATION BALLOON
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FGE
2004-06-24
LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
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FGE
2004-06-21
CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
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FGE
2004-05-10
MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
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FGE
2004-04-28
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
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FGE
2004-04-07
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
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FGE
2004-03-30
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
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FGE
2004-03-16
LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
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FGE
2004-03-16
ZILVER 635 BILIARY STENT
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FGE
2004-02-20
OASIS BILIARY STENT INTRODUCTION SYSTEM
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FGE
2004-02-17
WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
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FGE
2004-02-04
BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
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FGE
2004-02-04
DURAMAX .018 BILIARY STENT SYSTEM
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FGE
2004-01-02
OMNILINK .018 BILIARY STENT SYSTEM
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FGE
2003-12-22
CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
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FGE
2003-12-15
ZILVER 518 BILIARY STENT
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FGE
2003-12-10
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005
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FGE
2003-11-21
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
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FGE
2003-11-17
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
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FGE
2003-11-17
STONE EXTRACTOR BALLOON CATHETER
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FGE
2003-11-14
SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
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FGE
2003-11-10
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
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FGE
2003-10-30
LIFESTENT SDS BILIARY ENDOPROSTHESIS
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FGE
2003-10-23
MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
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FGE
2003-10-22
MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822
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FGE
2003-10-22
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
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FGE
2003-10-09
MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
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FGE
2003-09-25
SENTINOL NITINOL BILLARY STENT SYSTEM
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FGE
2003-09-24
GI SUPPLY BILIARY STENT
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FGE
2003-09-17
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2003-09-04
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2003-09-02
MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT
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FGE
2003-08-27
MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT
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FGE
2003-08-12
WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2003-08-08
PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
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FGE
2003-07-18
MODIFICATION TO COOK ZILVER BILIARY STENT
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FGE
2003-07-09
DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML
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FGE
2003-07-07
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2003-07-03
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
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FGE
2003-06-17
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
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FGE
2003-06-16
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
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FGE
2003-05-30
MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
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FGE
2003-05-06
LUMINEXX ENDOSCOPIC BILIARY STENT
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FGE
2003-04-16
PANCREATIC DRAINAGE TUBE
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FGE
2003-04-14
LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
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FGE
2003-03-31
JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810
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FGE
2003-03-25
BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
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