QIS

Esophageal, Mucosal, Electrical Characterization

Product code

QIS

Device name

Esophageal, Mucosal, Electrical Characterization

Device class

Class 2

21 CFR

21 CFR 876.1450

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-09-06.

1 summaries are archived here for direct download.