Cytology Brush
FDA 510(k) K780872 · CooperVision, Inc.
510(k) numberK780872
Submission
- Device name
- Cytology Brush
- Applicant
- CooperVision, Inc.
Southampton, GB - Received
- May 30, 1978
- Decision date
- September 7, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
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| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…LPL · Traditional | 03/23/2020SE |
| K190965 | MyDayLPL · Special | 04/29/2019SE |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV…LPL · Traditional | 12/11/2018SE |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact LensLPL · Traditional | 07/13/2016SE |
| K133627 | Avaira Spheric and Toric (Enfilcon a) Soft Contact LensLPL · Special | 12/23/2013SE |
| K131378 | Sus (Stenfilcon a) Contact LensLPL · Traditional | 08/30/2013SE |
Questions and answers
When was Cytology Brush cleared by the FDA?
Cytology Brush (K780872) received a 510(k) decision of Substantially Equivalent on September 7, 1978, 100 days after the submission was received.
What is the product code of K780872?
The FDA product code is BTG – Brush, Biopsy, Bronchoscope (Non-Rigid), a Class II (moderate risk) device regulated under 21 CFR 874.4680.