Single Use Cytology Brush BC-205D
FDA 510(k) clearance K190293 · decided 2019-08-02
Clearance details
- K-number
- K190293
- Device name
- Single Use Cytology Brush BC-205D
- Applicant
- Olympus Medical Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2019-02-11
- Decision date
- 2019-08-02
- Days to decision
- 172 days
- Clearance type
- Traditional
- Product code
- BTG
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Hachioji-Shi, JP
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.