K180086 is an FDA 510(k) clearance for the Gyrus ACMI ? EZDilate 3-Stage Balloon Dilatation Catheter, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on March 8, 2018, 55 days after receiving the submission on January 12, 2018. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K180086 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 12, 2018 |
| Decision Date | March 08, 2018 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FGE — Stents, Drains And Dilators For The Biliary Ducts |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5010 |