K924646 is an FDA 510(k) clearance for the OVER THE GUIDEWIRE DILATATION SYSTEM. This device is classified as a Dilator, Esophageal (Class II - Special Controls, product code KNQ).
Submitted by Medovations, Inc. (Germantown, US). The FDA issued a Cleared decision on December 5, 1994, 812 days after receiving the submission on September 14, 1992.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K924646 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 14, 1992 |
| Decision Date | December 05, 1994 |
| Days to Decision | 812 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 |