K082995 is an FDA 510(k) clearance for the SMART DILATOR, a Dilator, Esophageal (Class II — Special Controls, product code KNQ), submitted by Safestitch Medical (Miami, US). The FDA issued a Cleared decision on February 6, 2009, 121 days after receiving the submission on October 8, 2008. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K082995 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 08, 2008 |
| Decision Date | February 06, 2009 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KNQ — Dilator, Esophageal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.5365 |