FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MiVu Esophageal Endo Cap
K Number: K230056
·
Decision Apr 25, 2023
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
3
Review Days
106
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Basic Information
- Device Name
- MiVu Esophageal Endo Cap
- K Number
- K230056
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1450
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diversatek Healthcare
- Date Received
- January 9, 2023
- Decision Date
- April 25, 2023
- Product Code
- QIS
- Advisory Committee
- Gastroenterology, Urology
- 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 |
|---|---|---|---|
| QIS | Esophageal, Mucosal, Electrical Characterization | FDA class 2 | Gastroenterology, Urology |
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