K160403 is an FDA 510(k) clearance for the SmartStart Air/Water and Suction Valves, a Endoscope Channel Accessory (Class II — Special Controls, product code ODC), submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on May 19, 2016, 97 days after receiving the submission on February 12, 2016. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K160403 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 12, 2016 |
| Decision Date | May 19, 2016 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | ODC — Endoscope Channel Accessory |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Give The Endoscope Channel Additional Or Improved Functionality. |