FDX
- Product code
- FDX
- Device name
- Endoscopic Cytology Brush
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1500
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 44 (all years; only the last 3 years are listed here)
FDA classification definition
To collect cells for cytological evaluation.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K250993 | 2025-12-18 | Olympus Medical Systems Corporation | Single Use Cytology Brush V (BC-V600P-3010) |
Official FDA classification page: FDX
Classification and pathway per current FDA publications. Data from openFDA (CC0).