K932015 is an FDA 510(k) clearance for the TRI-MED INFLATABLE ESOPHAGEAL DILATOR. This device is classified as a Dilator, Esophageal (Class II - Special Controls, product code KNQ).
Submitted by Tri-Med Specialties, Inc. (Overland Park, US). The FDA issued a Cleared decision on February 3, 1994, 286 days after receiving the submission on April 23, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K932015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 1993 |
| Decision Date | February 03, 1994 |
| Days to Decision | 286 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | KNQ — Dilator, Esophageal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5365 |