K093236 is an FDA 510(k) clearance for the ETHICON ENDO-SURGERYOPTICAL DILATOR, a Dilator, Esophageal (Class II — Special Controls, product code KNQ), submitted by Ethicon Endo-Surgery, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 10, 2009, 26 days after receiving the submission on October 15, 2009. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5365.
| 510(k) Number | K093236 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 15, 2009 |
| Decision Date | November 10, 2009 |
| Days to Decision | 26 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 |