K120862 is an FDA 510(k) clearance for the WATER BOTTLE CAP IRRIGATON 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 November 27, 2012, 250 days after receiving the submission on March 22, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K120862 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 22, 2012 |
| Decision Date | November 27, 2012 |
| Days to Decision | 250 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 |