K900924 is an FDA 510(k) clearance for the WILSON-COOK BALLOON DILATION CATHETERS. This device is classified as a Dilator, Esophageal (Class II - Special Controls, product code KNQ).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on December 21, 1990, 297 days after receiving the submission on February 27, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K900924 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1990 |
| Decision Date | December 21, 1990 |
| Days to Decision | 297 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNQ — Dilator, Esophageal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5365 |