BTG
- Product code
- BTG
- Device name
- Brush, Biopsy, Bronchoscope (Non-Rigid)
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.4680
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 6
FDA classification definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K251279 | 2025-06-12 | Olympus Medical Systems Corporation | Disposable Cytology Brush BC-202D/203D Series summary |
Official FDA classification page: BTG
Classification and pathway per current FDA publications. Data from openFDA (CC0).