K142155 is an FDA 510(k) clearance for the ENDOCHOICE WATER BOTTLE CAP SYSTEM, a Pump, Air, Non-manual, For Endoscope (Class II — Special Controls, product code FEQ), submitted by Endochoice, Inc. (Alpharetta, US). The FDA issued a Cleared decision on January 20, 2015, 167 days after receiving the submission on August 6, 2014. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K142155 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 06, 2014 |
| Decision Date | January 20, 2015 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FEQ — Pump, Air, Non-manual, For Endoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |