BEUDAMED
    Product Code: FGE FDA class 2 21 CFR 876.5010

    Stents, Drains And Dilators For The Biliary Ducts

    Gastroenterology, Urology

    Biliary Duct Stents, Drains, and Dilators are devices used to maintain patency, provide drainage, or dilate strictures within the biliary ductal system, typically in the treatment of biliary obstruction from benign or malignant causes. They are classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is FGE, regulated under 21 CFR 876.5010, within the Gastroenterology, Urology specialty. This device is both an implant and is considered life-sustaining or life-supporting.

    View on FDA
    510(k)s
    474
    FEI Numbers
    143
    Registration Numbers
    143
    Unique Applicants
    141
    Years Active
    44

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    Basic Information

    Product Code
    FGE
    Device Class
    FDA class 2
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Review Panel
    GU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✓
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 474 510(k) clearances via K numbers.

    K Number Device Name
    K253832 Dilation Balloon Catheter
    K251658 Endoflux™ Biliary & Pancreatic Stent Sets
    K253987 BARE Wireguided Balloon Dilation Catheter (1235)
    K253132 Single use stone retrieval balloons
    K251123 Niti-S Biliary Stent; Niti-S Biliary Slim M Stent
    K251019 BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G
    K250409 Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disposable Balloon Catheter (B7-2LA)
    K251229 EndoFix™Tissue Fixation System
    K243412 ARCHIMEDES Biodegradable Pancreatic Stent
    K251291 Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
    K242845 EGIS Biliary Double Bare Stent (BDB080405)
    K241888 Single-use Balloon Dilatation Catheter
    K241801 Tornus ES
    K242950 WallFlex Biliary PLUS RX Stent System
    K240464 WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV
    K233079 Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)
    K232245 VedDilator ^TM (3-Stage Balloon Dilation Catheter)
    K232596 EndoGI S-Path Biliary Stent System
    K223354 EGIS Biliary Single Bare Stent
    K230127 Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible
    K223469 WallFlex™ Biliary RX Stent System
    K223626 Niti-S Biliary Speed D Stent
    K222663 MultiStage Balloon Dilatation Catheter
    K223592 Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers
    K222627 EndoGI S-Path Biliary Stent System
    K221071 Niti-S Biliary Slim M Stent
    K213946 Compass BDS Biliary Stent
    K211021 Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible
    K210419 BIOTEQ Drainage Catheter BT-PDS-series
    K202973 HANAROSTENT Benefit Biliary (NNN)
    K203162 Advanix Biliary Stent with NaviFlex RX Delivery System
    K200103 BIOTEQ Drainage Catheter Set (One Step Type)
    K202477 EndoGI S-Path Biliary Stent System
    K193600 EndoGI Biliary Stent System
    K181669 ConvertX Biliary Stent System
    K183396 HANAROSTENT FASTTM Biliary (NNN)
    K182980 Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
    K180418 Reliant(TM) Multistage Dilatation Balloon Catheter
    K180868 Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set
    K173035 Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets
    K172057 Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
    K180086 Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
    K172044 Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S
    K171548 Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter
    K172520 CRE RX Biliary Balloon Dilatation Catheter
    K171809 Epic Biliary Endoscopic Stent System
    K171623 Nasal Pancreatic Drainage Set
    K171223 Quantum TTC Biliary Balloon Dilator
    K170740 GORE VIABIL Short Wire Biliary Endoprosthesis
    K170743 AngioDynamics Total Abscession Biliary Drainage Catheter
    K163169 Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent
    K162226 Reliant Multistage Dilatation Balloon Catheter
    K163018 Zilver 635 Biliary Stent
    K162404 Express SD Biliary Monorail Premounted Stent System
    K161203 Soehendra Stent Retriever
    K150487 X-Suit NIR Biliary Metallic Stent
    K152853 WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary
    K151925 Elation Wireguided Balloon Dilation Catheter
    K152607 Express SD Biliary Monorail Premounted Stent System
    K151671 Disposable Multistage Dilation Balloon Catheter
    K152524 Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
    K152069 Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
    K143609 Gyrus ACMI - EZDilate 3-Stage Balloon Dilatation Catheter
    K143303 Single Use Biliary Balloon Dilator
    K141408 RESOLVE BILIARY LOCKING DRAINAGE CATHETER
    K141335 EXPEL APD DRAINAGE CATHETER SYSTEM
    K141597 MUSTANG BALLOON DIALATION CATHETER
    K133110 EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM
    K140760 BONASTENT BILIARY
    K140630 WALLFLEX BILIARY RX STENT SYSTEM
    K133700 ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
    K130981 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM
    K131201 ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
    K130792 LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
    K130484 MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
    K130591 SUPERA VERITAS
    K121430 EVOLUTION BILIARY STENT SYSTEM
    K122546 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K122072 WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE
    K111627 SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K121832 RESOLVE BILIARY LOCKING DRAINAGE CATHETER
    K121125 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
    K113582 ARCHSTENT BILIARY SYSTEM
    K120452 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
    K112994 CRE DITATATION BALLON
    K112522 FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
    K111149 HANAROSTENT BILIARY (NNN)
    K112543 WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM
    K112701 CHARGER BALLOON DILATATION CATHETER
    K111766 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
    K111315 MULTIPURPOSE DRAINAGE CATHETER
    K110122 MUSTANG BALLOON DILATAION CATHETERS
    K103478 SINGLE USE BILIARY DRAINAGE STENT V
    K103353 MULTIPURPOSE DRAINAGE CATHETER; NEPHROSTOMY DRAINAGE CATHETER; BILIARY DRAINAGE CATHETER
    K102519 FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX
    K093893 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K102082 EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
    K101786 ADVANIX DOUBLE PIGTAIL BILIARY STENT
    K101314 ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
    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
    K042518 ZILVER 518 BILIARY STENT
    K041962 XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605
    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
    K040550 LIFESTENT SDS AND XL SDS BILIARY ENDOPROSTHESIS
    K040505 ZILVER 635 BILIARY STENT
    K040151 OASIS BILIARY STENT INTRODUCTION SYSTEM
    K033909 WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
    K033497 BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
    K032436 DURAMAX .018 BILIARY STENT 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
    K033134 MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
    K011261 STONE EXTRACTOR BALLOON CATHETER
    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
    K032929 MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822
    K032580 PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
    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
    K031331 WZ SELF-EXPANDING STENT TRANSHEPATIC BILIARY SYSTEM
    K032206 PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION
    K031821 MODIFICATION TO COOK ZILVER BILIARY STENT
    K030638 DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML
    K031777 MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K024303 EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM
    K023666 RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
    K031197 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K030839 MEDTRONIC AVE BRIDGE AURORA BILIARY STENT SYSTEM (AURORA)
    K031186 LUMINEXX ENDOSCOPIC BILIARY STENT
    K021672 PANCREATIC DRAINAGE TUBE
    K023308 LIFESTENT SDS BILIARY ENDOPROSTHESIS, LIFESTENT XL SDS BILIARY ENDOPROSTHESIS
    K030053 JOSTENT SELFX, MODELS 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808; 015SX6810
    K030645 BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT
    K030107 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM
    K030409 SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM
    K023121 LIFESTENT BILIARY ENDOPROSTHESIS
    K023248 LIFESTENT LP SDS BILIARY ENDOPROSTHESIS
    K010714 EXPANDER, MODELS 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830
    K024048 MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
    K021994 BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM
    K023870 FLEXIMA BILIARY CATHETER
    K014215 VIABIL BILIARY ENDOPROSTHESIS
    K023243 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K023217 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K021630 BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
    K021898 SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K022026 MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
    K021824 DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010
    K021345 MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
    K021729 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K020788 WILSON-COOK ZILVER BILIARY STENT
    K020528 INTRASTENT LD (LARGE DIAMETER) STENT
    K020809 MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
    K020682 BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
    K013737 MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON
    K020052 SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K014184 MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
    K010549 BILIARY AND PANCREATIC ENDOPROSTHESES (STENTS)
    K014136 MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K014205 MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
    K014007 DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
    K011909 ULTRA-THIN SDS BALLOON DILATATION CATHETER
    K010601 FANELLI BILIARY STENT
    K012752 WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
    K012822 MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
    K011080 BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
    K012993 MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K012590 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
    K011806 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K010411 PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
    K012347 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K011817 BRIDGE FX
    K012216 NIROYAL BILIARY PREMOUNTED STENT SYSTEM
    K011184 INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
    K010242 COOK ZILVER BILIARY STENT
    K012090 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
    K012087 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
    K012066 PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K012056 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
    K010107 R STENT BILIARY ENDOPROSTHESIS
    K011881 DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
    K011506 OMNILINK .035 BILIARY STENT SYSTEM
    K011039 OMNILINK .018 BILIARY STENT SYSTEM
    K010684 RX HERCULINK PLUS BILIARY STENT SYSTEM
    K003929 NIROYAL BILIARY PREMOUNTED STENT SYSTEM
    K010445 PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
    K002650 VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-726
    K003997 INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
    K002235 HORIZONS ERCP CANNULA
    K003186 BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
    K003793 BARD LUMINEXX BILIARY STENT
    K003753 GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
    K003040 INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
    K003450 INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS
    K003365 S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
    K003336 MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K002130 NIR BILIARY STENT
    K002143 DYNALINK BILIARY SELF-EXPANDING STENT SYSTEM
    K002133 NIR BILLIARY STENT SYSTEM; MARSHAL BALLOON DILATATION CATHETER
    K001338 MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER
    K001648 INTRASTENT DOUBLESTRUT PARAMOUNT
    K002101 ANGIODYNAMICS ABSCESSION BILIARY DRAINAGE CATHETER
    K001843 S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K001258 BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM
    K000744 MEDTRONIC AVE BRIDGE X3 STENT
    K000308 WALLSTENT BILIARY ENDOPROSTHESIS
    K001224 RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
    K001222 OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1
    K000864 INTRASTENT DOUBLESTRUT XS STENT
    K000793 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
    K993303 SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
    K000564 CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
    K000550 OTW MEGALINK SDS BILIARY STENT SYSTEM
    K993904 INTRASTENT DOUBLESTRUT LD
    K994156 MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B
    K993892 DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45
    K993392 BARD MEMOTHERM FLEXX BILIARY STENT
    K993232 WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM
    K994068 S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K993646 S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K990808 PBN DILATORS
    K993588 MODIFICATION TO RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005126-13, 1005128-13, 1005130-13, 1005132-13, 1005134-13,
    K993091 PALMAZ XL TANSHEPATIC BILIARY STENTS
    K993145 MEDTRONIC AVE BRIDGE STENT
    K992816 MODIFICATION TO INTRASTENT
    K992319 RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
    K992755 CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE
    K990867 RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
    K990592 INTRASTENT II
    K992569 MEDTRONIC AVE BRIDGE STENT
    K991674 CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS
    K991929 INTRASTENT
    K991028 CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
    K992318 MEDTRONIC AVE BRIDGE STENT
    K990854 INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
    K991533 MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
    K991793 ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
    K983154 CYSTIC DUCT BALLOON DILATING CATHETER
    K991032 GUIDANT MEGALINK BILIARY STENT, MODEL FG1002949-58
    K990631 CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
    K983075 GUIDANT MEGALINK BILIARY STENT, MODEL #'S 1002949-18, 1002949-28, 1002949-38
    K990130 WILSON-COOK PANCREATIC WEDGE STENT
    K982346 ANGIODYNAMICS ANGIOSTENT BILIARY STENT SYSTEM
    K980823 CORDIS NITINOL STENT AND DELIVERY SYSTEM
    K983008 PERIPHERAL AVE STENT SYSTEM
    K973171 NIR BILIARY STENT
    K982508 FLEXIMA
    K982005 WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
    K980290 ITI STENT
    K980653 PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM
    K980372 MANAN VS ACCESS NEEDLE/SET
    K980191 MANAN BILIARY DRAINAGE CATHETER
    K974815 MANAN(TM) INTRODUCER SHEATH/NEEDLE
    K973008 COURIER ST BALLOON DILATATION CATHETER
    K972582 URESIL GUIDEWIRE
    K973113 MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM
    K971295 AVE BRIDGE STENT SYSTEM
    K972825 OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
    K973114 SILICONE BILIARY STENT/BILIARY CATHETER
    K972583 URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL BILIARY CATHETER, URESIL NEPHRO-URETERAL S
    K965147 BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
    K964688 LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT
    K963254 SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    K962899 ULTRAFLEX DIAMOND
    K963767 MANAN V.S. ACCESS NEEDLE/SET
    K963782 BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
    K964119 WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
    K970052 EXTRACTORRX
    K963691 COURIER BALLOON DILATATION CATHETER
    K963397 ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER
    K955110 NAVARRE PERCUTANEOUS BILIARY DRAINAGE
    K962925 OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
    K954713 DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
    K961216 MANAN INTRODUCER SHEALTH/NEEDLE
    K961262 WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS
    K955126 LMI BILIARY CATHETER
    K955728 CORDIS BILIARY STENT
    K954043 MANAN BILIARY DRAINAGE CATHETER
    K955413 ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER
    K953332 MS CLASSIQUE BALLOON DILATATION CAHTETER
    K945498 INSTENT ENDOCOIL-T(TM) TRANSHEPATIC BILIARY ENDOPROSTHESIS
    K924387 INSTENT ENDOCOIL BILIARY ENDOPROSTHESIS
    K953827 GIP/MEDI-GLOBE ERCP CATHETERS
    K941973 GIP/MEDI-GLOBE GUIDE WIRES & WIND-UP GUIDE WIRES
    K944912 OLYMPUS NBD TUBES
    K933200 OLYMPUS PBD STENTS
    K944143 MS CLASSIQUE BALLOON CATHETER
    K941350 WILSON-COOK GIANTURCO-ROSCH Z-STENT AND INTRODUCER
    K943143 BILIARY STENT
    K935094 BALLOON DILATION CATHETER
    K925406 BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM
    K923993 WALLSTENT BILIARY ENDOPROTHESES
    K930623 MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH
    K940370 AMERICAN CATHETER E.R.C.P. CANNULA
    K940965 ELIMINATOR BALLOON DILATOR
    K934377 INNERDYNE REMOTE RADIALLY EXPANDING DILATOR REMOTE R.E.D.
    K924608 HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS
    K931025 INTHERM STASIS VALVE SYSTEM
    K923096 URESIL BILLIARY CATHETER
    K924107 ERCP CANNULA
    K920361 BARD BILIARY BALLOON DILATORS
    K924451 INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR
    K921654 MCLEAN-STOCK PERCUTANEOUS T-TUBE SET
    K921191 GIANTURCO-ROSCH BILIARY Z STENT
    K920236 CHOLANGIOGRAM CATHETER KIT
    K915813 ACKRAD ERCP CONTRAST DELIVERY SET
    K914699 URESIL FIXATION DEVICE
    K914495 E.R.C.P. CATHETER
    K913986 CHOLANGIOGRAPHY/CHOLANGIOSCOPY/LIHOPAXY SYSTEM
    K914882 WILTEK BALLOON CHOLANGIOGRAPHY CATHETER
    K914881 WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
    K914277 WALLSTENT(R) TRANS BILIARY ENDO W/UNISTEP DELIV SY
    K913932 PERCUTANEOUS DILATOR WITH SHEATH
    K913073 DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT
    K913841 2 LUMEN ENDOS RETRO CHOLANGIOPANCREA INJEC CATH
    K911630 LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON
    K912288 WILTEK STANDARD CHOLANGIOGRAPHY CATHETER
    K912122 CHOLANGIOGRAPHY CATHETER
    K912971 INTHERM RADIALLY EXPANDING DILATER
    K900205 DRAINAGE CATHETERS W/A DISSOLVABLE TIP
    K911581 PALMAZ(TM) BALLOON-EXPANDABLE STENT, MODIFICATION
    K910671 MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
    K911292 SCHNEIDER WALLSTENT(R)
    K910219 LAPAROMED CHOLANGIOGRAM DEVICE
    K910931 BILIARY BALLOON DILATATION CATHETER
    K910493 AVD INTIMAX CHOLANGIOGRAPHY CATHETER
    K905738 OPERATIVE CHOLANGIOGRAPHIC CATHETER
    K910768 SURGITEK(R) 420 CM G.I. INFUSION GUIDEWIRE
    K904669 BALLOON CATHETERS
    K910006 AVD INTIMAX (TM) BILIARY CATHETER
    K905707 BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
    K905714 ERCP CANNULA
    K905229 LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS
    K900923 ZIMMON ENDOSCOPIC PANCREATIC STENT
    K903420 SOEHENDRA STENT RETRIEVER
    K903858 COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION
    K902734 PR CANNULAS
    K902107 WILSON-COOK SYRINGE HOLDERS
    K901582 DOBBHOFF BILIARY STENT SET
    K901427 BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON
    K901433 SURE-FLEX ANASTOMOTIC BALLOON DILATOR
    K901432 BILIARY BALLOON DILATOR
    K901431 TELEMED ERCP CANNULA
    K900904 CANDELA DIRECTABLE BILIARY CATHETER SYSTEM
    K896323 WILSON-COOK ENDOSCOPIC NASAL BILIARY DRAINAGE SETS
    K896391 BARD/ANGIOMED STENTS
    K896518 DOBBHOFF(R) ERCP CANNULA
    K896503 PORGES ERCP CATHETERS
    K896506 PORGES ENDOSCOPIC DORMIA EXTRACTORS, DORMIATRIPTOR
    K896504 PORGES 2-WAY BALLOON EXTRACTION CATHETER
    K896423 PORGES BILIARY STENTS
    K896376 PORGES NASOBILIARY DRAIN
    K894871 WILTEK BILIARY STENT SET
    K894867 WILTEK E.R.C.P. CATHETER
    K896069 WILSON-COOK GIANTURCO-ROSCH BILIARY Z STENT
    K896163 SCHNEIDER STENT WALLSTENT ENDOSCOPIC BILIARY ENDO.
    K884714 BILIARY DIALATOR
    K892384 BILIARY ENDOPROSTHESIS AND EXTERNAL CATHETER
    K892383 BILIARY ENDOPROSTHESIS FOR INTERNAL DRAINAGE SET
    K880343 BURNEY GALLBLADDER CATHETER KIT
    K882610 COOK-GIANTURCO BILIARY Z STENT
    K885180 EXPANDABLE BILIARY STENT ENDOPROSTHESIS
    K873606 MODIFIED COPE SUTURE ANCHOR
    K873954 NAMIC HAWKINS UNIVERSAL DRAINAGE SET
    K872509 LINDEN STONE EXTRACTION BALLOON
    K872458 AN3200 DOUBILET DRAIN
    K861291 GASTROTOPO
    K863571 BILIARY BALLOON CATHETER
    K862059 SHEATH, ENDOSCOPE
    K863437 BARD BALLOON DILATATION SYSTEM
    K863957 TUBEGRIPPER, DRAINAGE CATHETER & ACCESSORY FOR GU
    K861220 LUNDERQUIST - RING PTC DRAINAGE CATHETER
    K860990 ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY
    K855142 ANGIOMED PERCUTANEOUS TRANSHEPATIC CHOLANGIOGTAPHY
    K851962 ZIMMON BILIARY STENT SET
    K851954 PVL-4.8-200 BALLOON STONE EXTRACTOR
    K853666 ENDODYNAMICS SIEGEL THERAPUTIC STENT
    K852293 BARD-PARKER BILIARY BALLOON CATHETER
    K853543 DAVOL RETRIEVAL BALLOON CATHETER
    K851242 GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO
    K851960 SOEHENDRA BILIARY DILATING CATHETER-SBDC-7
    K851647 OLBERT CATHETER SYSTEM FOR BILIARY TRACT DILATATIO
    K851956 VPDS-1 VENNES PANCREATIC DILATION SET
    K844384 BILIARY STENT PROSTHESIS
    K842147 CATH-TECH CHOLANGIOGRAPHY CATHETER
    K834413 DILATION BALLOON CATHETER
    K834468 DRAINAGE STENT
    K834574 USCI ENDOPROSTHESIS
    K834351 BILIARY INDWELLING STENT
    K833937 UMI PERCUTANEOUS TRANSHEPATIC CHOLAN
    K833920 KELLY CHOLANGIOCATH
    K830483 COONS SOFT STENT
    K823428 KELLY INFLATABLE T DRAIN
    K821819 PIGTAIL STENTS
    K821817 PIGTAIL NASAL CATHETERS

    FEI Numbers

    This FDA classification entry is associated with 143 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 143 registration numbers. Click on an entry to view related FDA registrations.