K103437 is an FDA 510(k) clearance for the US ENDOSCOPY CYTOLOGY BRUSH. 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 December 23, 2010, 30 days after receiving the submission on November 23, 2010.
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 | K103437 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2010 |
| Decision Date | December 23, 2010 |
| Days to Decision | 30 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. |