K153588 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 February 24, 2016, 70 days after receiving the submission on December 16, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K153588 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 16, 2015 |
| Decision Date | February 24, 2016 |
| Days to Decision | 70 days |
| Submission Type | Special |
| 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 |