K250993 is an FDA 510(k) clearance for the Single Use Cytology Brush V (BC-V600P-3010). This device is classified as a Endoscopic Cytology Brush (Class II - Special Controls, product code FDX).
Submitted by Olympus Medical Systems Corporation (Hachioji-Shi, JP). The FDA issued a Cleared decision on December 18, 2025, 262 days after receiving the submission on March 31, 2025.
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 | K250993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 2025 |
| Decision Date | December 18, 2025 |
| Days to Decision | 262 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. |