510(k) K230056
K230056 is an FDA 510(k) premarket notification submitted by Diversatek Healthcare for the device "MiVu Esophageal Endo Cap". The FDA issued a decision of Substantially Equivalent on April 25, 2023. The device falls under product code QIS (Esophageal, Mucosal, Electrical Characterization), a Class II device regulated under 21 CFR 876.1450. Diversatek Healthcare has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2023
- Date Received
- January 9, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esophageal, Mucosal, Electrical Characterization
- Device Class
- Class II
- Regulation Number
- 876.1450
- Review Panel
- GU
- Submission Type
The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.