BTG
6 FDA 510(k) clearances · Product code
172 daysmedian time to decision
473 days90th percentile
6clearances measured
FDA profile
- Official device name
- Brush, Biopsy, Bronchoscope (Non-Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Medical specialty
- Ear, Nose, Throat
- Flags
- Third-party review eligible
- FDA 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).
- Adverse events (MAUDE)
- 2007: 3 · 2008: 25 · 2009: 4 · 2012: 9 · 2016: 8 · 2020: 11
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Disposable Cytology Brush BC-202D/203D Series (K251279) | Olympus Medical Systems Corporation | 2025-06-12 |
| Pulmonary Cytology Brush (K182927) | Hobbs Medical, Inc. | 2020-02-07 |
| Single Use Cytology Brush BC-205D (K190293) | Olympus Medical Systems Corp. | 2019-08-02 |
| SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH (K130357) | Covidien, LLC | 2013-11-06 |
| MICROBIOLOGY SPECIMEN BRUSH (K820771) | Mill-Rose Laboratory | 1982-05-03 |
| CYTOLOGY BRUSH (K780872) | CooperVision, Inc. | 1978-09-07 |
Track BTG automatically
Every clearance here is in the API, with alerts when new ones post.