K933845 is an FDA 510(k) clearance for the WILSON-COOK BALLOON INFLATION DEVICE. This device is classified as a Dilator, Esophageal (Class II - Special Controls, product code KNQ).
Submitted by Wilson-Cook Medical, Inc. (West Lafayette, US). The FDA issued a Cleared decision on November 29, 1994, 480 days after receiving the submission on August 6, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K933845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 1993 |
| Decision Date | November 29, 1994 |
| Days to Decision | 480 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 |