FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
CYTOLOGY BRUSH
K Number: K780872
·
Decision Sep 7, 1978
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
5
Applicant Total
97
Review Days
100
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CYTOLOGY BRUSH
- K Number
- K780872
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- CooperVision, Inc.
- Date Received
- May 30, 1978
- Decision Date
- September 7, 1978
- Product Code
- BTG
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTG | Brush, Biopsy, Bronchoscope (Non-Rigid) | FDA class 2 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTG), ordered by most recent decision date.
Disposable Cytology Brush BC-202D/203D Series
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Pulmonary Cytology Brush
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Single Use Cytology Brush BC-205D
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
MICROBIOLOGY SPECIMEN BRUSH
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Other Clearances by CooperVision, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K234127 | Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker | Jan 25, 2024 | Substantially Equivalent |
| K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | Feb 4, 2022 | Substantially Equivalent |
| K213164 | Avaira Vitality | Oct 26, 2021 | Substantially Equivalent |
| K202756 | Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) | Oct 20, 2020 | Substantially Equivalent |
| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC | Mar 23, 2020 | Substantially Equivalent |
| K190965 | MyDay | Apr 29, 2019 | Substantially Equivalent |
| K181920 | Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker | Dec 11, 2018 | Substantially Equivalent |
| K160803 | Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens | Jul 13, 2016 | Substantially Equivalent |
| K133627 | AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS | Dec 23, 2013 | Substantially Equivalent |
| K131378 | SUS (STENFILCON A) CONTACT LENS | Aug 30, 2013 | Substantially Equivalent |