BTG — Brush, Biopsy, Bronchoscope (Non-Rigid) Class II
Classification Details
- Product Code
- BTG
- Device Class
- Class II
- Regulation Number
- 874.4680
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
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).
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251279 | olympus medical systems corporation | Disposable Cytology Brush BC-202D/203D Series | June 12, 2025 |
| K182927 | hobbs medical | Pulmonary Cytology Brush | February 7, 2020 |
| K190293 | olympus medical systems | Single Use Cytology Brush BC-205D | August 2, 2019 |
| K130357 | covidien | SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH | November 6, 2013 |
| K820771 | mill-rose laboratory | MICROBIOLOGY SPECIMEN BRUSH | May 3, 1982 |
| K780872 | coopervision | CYTOLOGY BRUSH | September 7, 1978 |