K151345 is an FDA 510(k) clearance for the BioGuard Air/Water Valve, BioGuard Suction Valve. This device is classified as a Endoscope Channel Accessory (Class II - Special Controls, product code ODC).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on August 25, 2015, 98 days after receiving the submission on May 19, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Give The Endoscope Channel Additional Or Improved Functionality..
| 510(k) Number | K151345 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 19, 2015 |
| Decision Date | August 25, 2015 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | ODC - Endoscope Channel Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Give The Endoscope Channel Additional Or Improved Functionality. |