510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230056Substantially Equivalent

MiVu™ Esophageal Endo Cap

Diversatek Healthcare Inc, Highlands Ranch CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230056 is the FDA 510(k) clearance record for MiVu™ Esophageal Endo Cap, a class II device, cleared for Diversatek Healthcare on under FDA product code QIS (Esophageal, Mucosal, Electrical Characterization). FDA's definition for product code QIS reads: "The esophageal tissue characterization system is intended for obtaining measurements of electrical properties within esophageal tissue". FDA records list 20 510(k) clearances for Diversatek Healthcare, from to . As of , FDA records show no recalls naming K230056.

Clearance record

Decision date
Received
(106 days to decision)
Product code
QIS Esophageal, Mucosal, Electrical Characterization
Regulation
21 CFR 876.1450
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Diversatek Healthcare 9150 Commerce Center Cir. Suite 500, Highlands Ranch CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QIS

Trailing 12 months

FDA records hold no clearances under product code QIS in the trailing twelve months.

FDA records show no clearances under product code QIS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QIS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260