Submission Details
| 510(k) Number | K170743 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 10, 2017 |
| Decision Date | March 30, 2017 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
K170743 is an FDA 510(k) clearance for the AngioDynamics Total Abscession Biliary Drainage Catheter, a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by AngioDynamics, Inc. (Queensburgy, US). The FDA issued a Cleared decision on March 30, 2017, 20 days after receiving the submission on March 10, 2017. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K170743 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 10, 2017 |
| Decision Date | March 30, 2017 |
| Days to Decision | 20 days |
| Submission Type | Special |
| 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 |