K041648 is an FDA 510(k) clearance for the NITI-S STENT & INTRODUCER, MODEL EOXXXX. This device is classified as a Prosthesis, Esophageal (Class II - Special Controls, product code ESW).
Submitted by Taewoong Medical Co., Ltd. (Houston, US). The FDA issued a Cleared decision on April 28, 2005, 315 days after receiving the submission on June 17, 2004.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.3610.
| 510(k) Number | K041648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2004 |
| Decision Date | April 28, 2005 |
| Days to Decision | 315 days |
| Submission Type | Traditional |
| 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 |