510(k) K180086 · FGE Stents, Drains And Dilators For The Biliary Ducts
Gyrus ACMI EZDilate 3-Stage Balloon Dilatation Catheter
| Applicant | Gyrus Acmi, Inc., Southborough MA, US |
| Decision | Substantially Equivalent, Mar 8, 2018 |
| Received | Jan 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180086
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endosco Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-0880 Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1080 Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1380 Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1580 Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1880 Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-2080 Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years)
Model: BD-410X-0855 Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years)
Model: BD-410X-1055 Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years).
Model: BD-410X-1355 Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years).
Model: BD-410X-1555 Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years).
Model: BD-410X-1855 Open, Classified |
FGE | None listed |
| Jan 31, 2024 | Olympus Corporation of the Americas EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years).
Model: BD-410X-2055 Open, Classified |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.