K250993
- 510(k) number
- K250993
- Device name
- Single Use Cytology Brush V (BC-V600P-3010)
- Applicant
- Olympus Medical Systems Corporation JP
- Product code
- FDX — Endoscopic Cytology Brush
- Decision date
- 2025-12-18
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250993.pdf
Official FDA record: K250993
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.