K151889 is an FDA 510(k) clearance for the Infinity ERCP Sampling Device. This device is classified as a Endoscopic Cytology Brush (Class II - Special Controls, product code FDX).
Submitted by United States Endoscopy Group, Inc. (Mentor, US). The FDA issued a Cleared decision on July 30, 2015, 20 days after receiving the submission on July 10, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500. To Collect Cells For Cytological Evaluation..
| 510(k) Number | K151889 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2015 |
| Decision Date | July 30, 2015 |
| Days to Decision | 20 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FDX - Endoscopic Cytology Brush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |
| Definition | To Collect Cells For Cytological Evaluation. |