FDA 510(k)

MiVu™ Esophageal Endo Cap

K-Number: K230056 · 2023-04-25

Decision Date2023-04-25

Product CodeQIS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MiVu™ Esophageal Endo Cap is the device name listed in this FDA 510(k) record. The listed applicant is Diversatek Healthcare. It received FDA 510(k) clearance on 2023-04-25 under 510(k) number K230056. The device is classified under product code QIS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MiVu™ Esophageal Endo Cap?

MiVu™ Esophageal Endo Cap is a medical device that received FDA 510(k) clearance on 2023-04-25. The listed applicant is Diversatek Healthcare. The 510(k) number is K230056.

When did MiVu™ Esophageal Endo Cap receive FDA 510(k) clearance?

MiVu™ Esophageal Endo Cap received FDA 510(k) clearance on 2023-04-25, under 510(k) number K230056.

Who is the listed applicant for MiVu™ Esophageal Endo Cap?

The FDA 510(k) record lists Diversatek Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MiVu™ Esophageal Endo Cap?

The FDA product code for MiVu™ Esophageal Endo Cap is QIS.

Other records listing Diversatek Healthcare as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222734Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing K190208Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe

Related Devices (Code: QIS)

K233974Mucosal Impedance Measurement SystemAlandra Medical Sapi DE CV

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.