K202973 is an FDA 510(k) clearance for the HANAROSTENT Benefit Biliary (NNN), a Stents, Drains And Dilators For The Biliary Ducts (Class II — Special Controls, product code FGE), submitted by M.I. Tech Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on May 11, 2021, 223 days after receiving the submission on September 30, 2020. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5010.
| 510(k) Number | K202973 FDA.gov |
| FDA Decision | Cleared SESU |
| Date Received | September 30, 2020 |
| Decision Date | May 11, 2021 |
| Days to Decision | 223 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 |