K191559 is an FDA 510(k) clearance for the AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM. This device is classified as 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 August 1, 2019, 49 days after receiving the submission on June 13, 2019.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K191559 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2019 |
| Decision Date | August 01, 2019 |
| Days to Decision | 49 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 |