Single Use Cytology Brush BC-205D
FDA 510(k) K190293 · Olympus Medical Systems Corp.
510(k) numberK190293
Submission
- Device name
- Single Use Cytology Brush BC-205D
- Applicant
- Olympus Medical Systems Corp.
Hachioji-Shi, JP - Received
- February 11, 2019
- Decision date
- August 2, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTG – Brush, Biopsy, Bronchoscope (Non-Rigid)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4680
- Specialty
- 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).
Other 510(k)s with product code BTG
| 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 |
| 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 |
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| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional | 08/27/2026SE |
| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)PSV · Traditional | 08/27/2026SE |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | 07/31/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | 07/01/2026SE |
| K261260 | HD Camera Head OLYMPUS CH-S200-08-LBFET · Traditional | 06/24/2026SE |
| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…PKL · Traditional | 05/21/2026SE |
| K252341 | Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional | 04/23/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | 03/20/2026SE |
Questions and answers
When was Single Use Cytology Brush BC-205D cleared by the FDA?
Single Use Cytology Brush BC-205D (K190293) received a 510(k) decision of Substantially Equivalent on August 2, 2019, 172 days after the submission was received.
What is the product code of K190293?
The FDA product code is BTG – Brush, Biopsy, Bronchoscope (Non-Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.