MiVu™ Esophageal Endo Cap

FDA 510(k) K230056 · Diversatek Healthcare

Substantially Equivalent

510(k) numberK230056

Submission

Device name
MiVu™ Esophageal Endo Cap
Applicant
Diversatek Healthcare
Highlands Ranch, CO, US
Received
January 9, 2023
Decision date
April 25, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QIS – Esophageal, Mucosal, Electrical Characterization
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1450
Specialty
Gastroenterology, Urology

The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue.

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Questions and answers

When was MiVu™ Esophageal Endo Cap cleared by the FDA?

MiVu™ Esophageal Endo Cap (K230056) received a 510(k) decision of Substantially Equivalent on April 25, 2023, 106 days after the submission was received.

What is the product code of K230056?

The FDA product code is QIS – Esophageal, Mucosal, Electrical Characterization, a Class II (moderate risk) device regulated under 21 CFR 876.1450.