FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
EndoSign® Cell collection device (ES-CYT-102)
K Number: K233142
·
Decision Jan 19, 2024
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
29
Applicant Total
1
Review Days
114
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Basic Information
- Device Name
- EndoSign® Cell collection device (ES-CYT-102)
- K Number
- K233142
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4710
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cyted Limited
- Date Received
- September 27, 2023
- Decision Date
- January 19, 2024
- Product Code
- EOX
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| EOX | Esophagoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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