K896318 is an FDA 510(k) clearance for the WILSON-COOK CYTOLOGY BRUSHES. This device is classified as a Endoscopic Cytology Brush (Class II - Special Controls, product code FDX).
Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on April 9, 1990, 159 days after receiving the submission on November 1, 1989.
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 | K896318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1989 |
| Decision Date | April 09, 1990 |
| Days to Decision | 159 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| 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. |