FGE
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 472
Adverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code FGE
1–100 of 472- 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 — EndoFixTissue 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
- K111149 — HANAROSTENT BILIARY (NNN)
- K112522 — FLEXSTENT BILIARY SELF-EXPANDING STENT SYSTEM
- 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
- K101314 — ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM
- K101786 — ADVANIX DOUBLE PIGTAIL BILIARY STENT
- K101095 — DIRECT PERORAL CHOLANGIOSCOPY BALLOON
- K093003 — BONASTENT BILIARY
- K092352 — SCUBA BILIARY STENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.