FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
K Number: K203450
·
Decision May 4, 2021
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
29
Applicant Total
1
Review Days
162
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Basic Information
- Device Name
- EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)
- K Number
- K203450
- 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
- Capnostics, LLC
- Date Received
- November 23, 2020
- Decision Date
- May 4, 2021
- 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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