K191485 is an FDA 510(k) clearance for the Deflectable Brush Biopsy Set. This device is classified as a Endoscopic Cytology Brush (Class II - Special Controls, product code FDX).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on June 26, 2019, 22 days after receiving the submission on June 4, 2019.
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 | K191485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2019 |
| Decision Date | June 26, 2019 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |