K183616 is an FDA 510(k) clearance for the HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN). This device is classified as a Stent, Colonic, Metallic, Expandable (Class II - Special Controls, product code MQR).
Submitted by M.I. Tech Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on January 10, 2019, 15 days after receiving the submission on December 26, 2018.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K183616 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 2018 |
| Decision Date | January 10, 2019 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | MQR - Stent, Colonic, Metallic, Expandable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3610 |