MiVu Esophageal Endo Cap
K-Number: K230056 · 2023-04-25
ApplicantDiversatek Healthcare
Decision Date2023-04-25
Product CodeQIS
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
MiVu Esophageal Endo Cap is a medical device manufactured by Diversatek Healthcare. It received FDA 510(k) clearance on 2023-04-25 under approval 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. It is manufactured by Diversatek Healthcare. The 510(k) number is K230056.
When was MiVu Esophageal Endo Cap approved by the FDA?
MiVu Esophageal Endo Cap received FDA 510(k) clearance on 2023-04-25, under approval number K230056.
What company makes MiVu Esophageal Endo Cap?
MiVu Esophageal Endo Cap is manufactured by Diversatek Healthcare.
What is the FDA product code for MiVu Esophageal Endo Cap?
The FDA product code for MiVu Esophageal Endo Cap is QIS.
Other Devices by Diversatek Healthcare
Related Devices (Code: QIS)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.