K090183 is an FDA 510(k) clearance for the HERCULES 3 STAGE WIRE GUIDED DILATION BALLOON, a Dilator, Esophageal (Class II — Special Controls, product code KNQ), submitted by Cook Endoscopy (Winstrom-Salem, US). The FDA issued a Cleared decision on September 25, 2009, 242 days after receiving the submission on January 26, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K090183 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 26, 2009 |
| Decision Date | September 25, 2009 |
| Days to Decision | 242 days |
| Submission Type | Special |
| 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 |