K061937 is an FDA 510(k) clearance for the COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON. This device is classified as a Dilator, Esophageal (Class II - Special Controls, product code KNQ).
Submitted by Cook Endoscopy (Winston-Salem, US). The FDA issued a Cleared decision on December 1, 2006, 144 days after receiving the submission on July 10, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K061937 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2006 |
| Decision Date | December 01, 2006 |
| Days to Decision | 144 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 |