K080782 is an FDA 510(k) clearance for the NITI-S ESOPHAGEAL STENT. This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).
Submitted by Taewoong Medical Co., Ltd. (Dunwoody, US). The FDA issued a Cleared decision on January 30, 2009, 317 days after receiving the submission on March 19, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K080782 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 19, 2008 |
| Decision Date | January 30, 2009 |
| Days to Decision | 317 days |
| Submission Type | Abbreviated |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ESW — Prosthesis, Esophageal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.3610 |