K153362 is an FDA 510(k) clearance for the AquaShield system CO2, AquaShield system-PENTAX, a Pump, Air, Non-manual, For Endoscope (Class II — Special Controls, product code FEQ), submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on December 16, 2015, 26 days after receiving the submission on November 20, 2015. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K153362 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 20, 2015 |
| Decision Date | December 16, 2015 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FEQ — Pump, Air, Non-manual, For Endoscope |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |