CYTOLOGY BRUSH
FDA 510(k) clearance K780872 · decided 1978-09-07
Clearance details
- K-number
- K780872
- Device name
- CYTOLOGY BRUSH
- Applicant
- CooperVision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-05-30
- Decision date
- 1978-09-07
- Days to decision
- 100 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
- Southampton, GB
- 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 |
| 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 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 220 cm, package recall (Z-0376-06) | Boston Scientific Corp | 2006-01-11 |
| Boston Scientific brand Microbiology Specimen Brush, single use, sterile, 90 cm, package o recall (Z-0377-06) | Boston Scientific Corp | 2006-01-11 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S033) | CooperVision, Inc. | 2025-12-23 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S032) | CooperVision, Inc. | 2025-12-17 |
| Biofinity XR Toric and Biofinity Toric Multifocal (Comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S193) | CooperVision, Inc. | 2025-12-11 |
| Sofmed® breathables XW NEXT (P080011/S191) | CooperVision, Inc. | 2025-12-05 |
| MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (P180035/S031) | CooperVision, Inc. | 2025-10-28 |
| Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (P080011/S192) | CooperVision, Inc. | 2025-09-22 |
| up&up Monthly Performance + (P080011/S184) | CooperVision, Inc. | 2025-08-20 |
| iWear oxygen presbyopia (P080011/S186) | CooperVision, Inc. | 2025-08-20 |