DeviceClearance

Product code QIS— Gastroenterology, Urology

MiVu Esophageal Endo Cap

Classification name
Esophageal, Mucosal, Electrical Characterization
Device class
Class 2
Regulation
21 CFR 876.1450
Advisory panel
Gastroenterology, Urology
Total cleared
3
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QIS under 21 CFR 876.1450, via openFDA

Market context for product code QIS

FDA has cleared 3 devices under product code QIS between 2019 and 2024, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QIS

Recent clearances under product code QIS

Data sourced from openFDA. This site is unofficial and independent of the FDA.