# K230056: MiVu™ Esophageal Endo Cap

- Pathway: 510(k) (Traditional)
- Applicant: Diversatek Healthcare
- Decided: Apr 25, 2023 after 106 days
- Product code: QIS (Esophageal, Mucosal, Electrical Characterization)
- Device class: 2
- Regulation: 21 CFR 876.1450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180067 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180067: Mucosal Integrity Conductivity (MI) Test System, Diversatek Healthcare, Inc. (2019) Summary page 5.

## Indications for use
The MiVu Mucosal Integrity Testing System is indicated for use by gastroenterologists, surgeons, and medical personnel trained in endoscopic procedures during an endoscopy to obtain real-time measurement of esophageal epithelial integrity as an adjunct for the evaluation of esophageal disorders. The device is not for use as a sole diagnostic screening tool.

Source page: https://510kreport.com/device/K230056
Methodology: https://510kreport.com/methodology