K043605 is an FDA 510(k) clearance for the INSCOPE 3-STAGE BALLOON DILATOR, a Dilator, Esophageal (Class II — Special Controls, product code KNQ), submitted by Cordis Europa, N.V. (Roden, Drenthe, NL). The FDA issued a Cleared decision on February 4, 2005, 36 days after receiving the submission on December 30, 2004. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K043605 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 30, 2004 |
| Decision Date | February 04, 2005 |
| Days to Decision | 36 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 |