Product code FGE— Gastroenterology, Urology
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- Classification name
- Stents, Drains And Dilators For The Biliary Ducts
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 476
- First cleared
- Most recent
Clearances under product code FGE — page 2
101–200 of 476- K101786 — ADVANIX DOUBLE PIGTAIL BILIARY STENT
- K101095 — DIRECT PERORAL CHOLANGIOSCOPY BALLOON
- K093003 — BONASTENT BILIARY
- K092352 — SCUBA BILIARY STENT SYSTEM
- K093947 — ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC
- K093392 — MULTIPURPOSE, NEPHROSTOMY AND BILIARY DRAINAGE CATHETERS
- K081996 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
- K082093 — BULLSEYE BILIARY STENT SYSTEM
- K083374 — WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
- K083627 — WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
- K090133 — CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
- K081956 — MEDINOL X-SUIT NIR BILIARY METALLIC STENT
- K073667 — NITI-S BILIARY STENT
- K081733 — 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
- K072708 — ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
- K080037 — MODIFICATION TO ZILVER 635 BILIARY STENT
- K081184 — GORE VIABIL BILILARY ENDOPROSTHESIS
- K063532 — BARD E LUMINEXX BILIARY STENT
- K072720 — ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM
- K072301 — 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
- K062798 — SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
- K071646 — SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
- K073672 — SKATER BILIARY CATHETER
- K063733 — RESOLVE BILIARY DRAINAGE CATHETER
- K062264 — COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM
- K063481 — MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
- K070610 — SKATER BILIARY CATHETER
- K061231 — WELLFLEX BILIARY RX STENT SYSTEM
- K061566 — PRIMUS GPS BILIARY STENT SYSTEM
- K060557 — SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060
- K060624 — MARATHON STENT WITH FUSION TECHNOLOGY
- K060817 — OMNILINK. 018 BILIARY STENT SYSTEM
- K061235 — LIFESTENT TURBO BILIARY STENT SYSTEM
- K060877 — PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
- K053459 — OMNILINK .035 BILIARY STENT SYSTEM
- K060487 — LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM
- K060023 — ANGIODYNAMICS TOTAL ABSCESSION BILIARY DRAINAGE CATHETER
- K060057 — PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM
- K053454 — RX HERCULINK ELITE BILIARY STENT SYSTEM
- K053404 — LIFESTENT FLEXSTART BILIARY STENT SYSTEM
- K053245 — GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIG DRAINAGE CATHETER; NEPHROSTOMY CATHETER; BILIARY CATHETER
- K052539 — COOK FORMULA 418 BILIARY STENT SYSTEM
- K052114 — BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
- K052132 — MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
- K051785 — FORMULA 418 BILIARY STENT
- K051124 — ZILVER 635 BILIARY STENT
- K050502 — SINGLE USE BALLOON DILATOR MAXPASSTM
- K051379 — PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT
- K050534 — XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
- K050777 — PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
- K050725 — PROTEGE GPS SELF-EXPANDING NITINOL STENT
- K050698 — MODIFICATION TO:ZILVER 518 BILIARY STENT
- K050627 — LIFESTENT TURBO BILIARY STENT SYSTEMS
- K050501 — MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
- K050103 — XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
- K033862 — BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK
- K043481 — MODIFICATION TO: ZILVER 635 BILIARY STENT
- K042985 — LIFESTENT NT35 BILIARY STENT SYSTEM
- K043243 — PRIMUS STENT AND DELIVERY SYSTEM
- K042969 — MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K041962 — XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
- K042518 — ZILVER 518 BILIARY STENT
- K042204 — MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT
- K041796 — PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K041423 — VIABIL BILIARY ENDOPROSTHESIS
- K041606 — EXTRACTOR RX RETRIEVAL BALLOON
- K040930 — ZILVER BILIARY STENT SYSTEM USW
- K040800 — WILOSN-COOK BILIARY DILATION BALLOON
- K041370 — LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
- K040413 — CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
- K041032 — MODIFICATION TO LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
- K040653 — PARAMOUNT MINI GPS BILIARY STENT SYSTEM
- K040667 — XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
- K040027 — BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
- K040505 — ZILVER 635 BILIARY STENT
- K040550 — LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
- K040151 — OASIS BILIARY STENT INTRODUCTION SYSTEM
- K033909 — WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
- K032436 — DURAMAX .018 BILIARY STENT SYSTEM
- K033497 — BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
- K033834 — OMNILINK .018 BILIARY STENT SYSTEM
- K033394 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
- K033348 — ZILVER 518 BILIARY STENT
- K033537 — SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005
- K033314 — PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
- K011261 — STONE EXTRACTOR BALLOON CATHETER
- K033134 — MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
- K033333 — SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
- K033393 — ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
- K033212 — LIFESTENT SDS BILIARY ENDOPROSTHESIS
- K032530 — MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
- K032580 — PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
- K032929 — MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822
- K032768 — MEDTRONIC, INC. RACER BILIARY STENT SYSTEM (RACER), MODEL XD#YF(L)
- K032025 — SENTINOL NITINOL BILLARY STENT SYSTEM
- K031360 — GI SUPPLY BILIARY STENT
- K032137 — PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K032457 — MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- K030633 — MEDTRONIC AVE BRIDGE CONSTANT BILIARY STENT SYSTEM OR ('CONSTANT
- K032360 — MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT
Data sourced from openFDA. This site is unofficial and independent of the FDA.