Brush, Biopsy, Bronchoscope (Non-Rigid)
FDA product code BTG · Class II (moderate risk) · 21 CFR 874.4680 · Ear, Nose, Throat
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).
6510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251279 | Disposable Cytology Brush BC-202D/203D SeriesBTG · Traditional | Olympus Medical Systems Corporation | 06/12/2025SE |
| K182927 | Pulmonary Cytology BrushBTG · Traditional | Hobbs Medical, Inc. | 02/07/2020SE |
| K190293 | Single Use Cytology Brush BC-205DBTG · Traditional | Olympus Medical Systems Corp. | 08/02/2019SE |
| K130357 | Superdimension Triple-Needle Cytology BrushBTG · Traditional | Covidien, LLC | 11/06/2013SE |
| K820771 | Microbiology Specimen BrushBTG · Traditional | Mill-Rose Laboratory | 05/03/1982SE |
| K780872 | Cytology BrushBTG · Traditional | CooperVision, Inc. | 09/07/1978SE |