{"entity":{"id":"self-expanding-metal-stents","kind":"technology","name":"Self-expanding metal stents for malignant obstruction (oesophagus, duodenum, colon, bile duct, airway)","aka":["SEMS","Self-expanding metal stent","Oesophageal stent","Duodenal stent","Colonic stent","Biliary metal stent","Airway stent","Tracheal stent","WallFlex","HANAROSTENT","Niti-S","Zilver"],"tldr":"Mesh tubes that spring open inside a gullet, bowel, bile duct or airway narrowed by cancer, to let food, stool, bile or air through again. Most are put in through an endoscope without an operation.","summary":"The FDA classes oesophageal (ESW), colonic (MQR) and duodenal (MUM) metal stents under 21 CFR 878.3610, biliary stents under 876.5010 (FGE) and expandable tracheal prostheses under 878.3720 (JCT, and NYT for polymeric). Current lines include Boston Scientific's WallFlex oesophageal (K261978, 10 July 2026), colonic and duodenal (K234046, 8 March 2024) and biliary RX stents (K240464, 30 August 2024), M.I.Tech's HANAROSTENT (K253327, 30 October 2025), Taewoong Medical's Niti-S oesophageal (K243619, 30 October 2025) and Niti-S duodenal and colonic Comfort stents (K250663, 31 March 2025), and Cook's Zilver 518 and 635 biliary stents (K182980, 16 November 2018). The glossary covers biliary stents and their problems, duodenal stenting and colorectal obstruction; the biliary stenting record covers the procedure.","status":"standard-of-care","asOf":"2026-11-04","links":[{"label":"FDA 510(k) K261978: WallFlex oesophageal stent (10 July 2026)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261978"},{"label":"FDA 510(k) K234046: WallFlex colonic and duodenal stents (8 March 2024)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K234046"},{"label":"FDA 510(k) K240464: WallFlex biliary RX stent (30 August 2024)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K240464"},{"label":"FDA 510(k) K253327: HANAROSTENT oesophagus upper (30 October 2025)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253327"},{"label":"FDA 510(k) K243619: Niti-S oesophageal stent (30 October 2025)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K243619"},{"label":"FDA 510(k) K250663: Niti-S duodenal and colonic Comfort stents (31 March 2025)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250663"},{"label":"FDA 510(k) K182980: Zilver 518 and 635 biliary stents (16 November 2018)","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K182980"},{"label":"FDA product code JCT: expandable tracheal prosthesis","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=JCT"}],"tags":["devices-gaps-2026-11"],"related":[],"cancers":["esophageal","pancreatic","colorectal","cholangiocarcinoma","gastric","nsclc"],"sections":["supportive-care","surgery","devices"],"technologies":["biliary-stenting-drainage","ureteric-stents-and-nephrostomy","cholangioscopy","palliative-care"],"targets":[],"drugs":[],"companies":["boston-scientific","cook-medical"],"institutions":[],"pathways":[],"terms":["biliary-stent","biliary-drainage-routes","duodenal-stenting-gastric-outlet","colorectal-palliation-obstruction-pain"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo device gap fill (openFDA, accessdata.fda.gov, NICE, Europe PMC, maker pages)","editedOn":"2026-11-04"},"principle":"A nitinol or stainless steel mesh, bare or covered with a membrane against tumour ingrowth, is constrained on a delivery system, positioned across the stricture under endoscopic or fluoroscopic guidance and released to expand radially.","strengths":["Relieves obstruction without surgery","Rapid return to eating or bowel function"],"limitations":["Migration, tumour ingrowth and re-blockage","Pain and bleeding"],"since":2018},"route":"/technologies/self-expanding-metal-stents/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"},{"id":"gastric","kind":"cancer","name":"Gastric & gastro-oesophageal junction cancer","route":"/cancers/gastric/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"esophageal","kind":"cancer","name":"Oesophageal cancer","route":"/cancers/esophageal/"},{"id":"pancreatic","kind":"cancer","name":"Pancreatic ductal adenocarcinoma","route":"/cancers/pancreatic/"}],"section":[{"id":"devices","kind":"section","name":"Devices & Physical Therapies","route":"/fronts/devices/"},{"id":"supportive-care","kind":"section","name":"Supportive Care & Survivorship","route":"/fronts/supportive-care/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"technology":[{"id":"biliary-stenting-drainage","kind":"technology","name":"Biliary stenting and drainage","route":"/technologies/biliary-stenting-drainage/"},{"id":"palliative-care","kind":"technology","name":"Early integrated palliative care","route":"/technologies/palliative-care/"},{"id":"cholangioscopy","kind":"technology","name":"Single-operator cholangioscopy (SpyGlass DS)","route":"/technologies/cholangioscopy/"},{"id":"ureteric-stents-and-nephrostomy","kind":"technology","name":"Ureteric stents and nephrostomy tubes for malignant ureteric obstruction (Memokath 051)","route":"/technologies/ureteric-stents-and-nephrostomy/"}],"company":[{"id":"boston-scientific","kind":"company","name":"Boston Scientific","route":"/companies/boston-scientific/"},{"id":"cook-medical","kind":"company","name":"Cook Medical","route":"/companies/cook-medical/"}],"term":[{"id":"biliary-drainage-routes","kind":"term","name":"Biliary drainage routes: ERCP stent, percutaneous (PTC) and EUS-guided","route":"/terms/biliary-drainage-routes/"},{"id":"duodenal-stenting-gastric-outlet","kind":"term","name":"Duodenal stenting and gastrojejunostomy for malignant gastric outlet obstruction","route":"/terms/duodenal-stenting-gastric-outlet/"},{"id":"colorectal-palliation-obstruction-pain","kind":"term","name":"Palliation in colorectal cancer: obstruction, stents, stomas and liver capsule pain","route":"/terms/colorectal-palliation-obstruction-pain/"},{"id":"biliary-stent","kind":"term","name":"Stenting (biliary, oesophageal, airway)","route":"/terms/biliary-stent/"}]}}