PIE

Esophageal Dilator With Balloon And Electrode Sensors

Product code

PIE

Device name

Esophageal Dilator With Balloon And Electrode Sensors

Device class

Class 2

21 CFR

21 CFR 876.5980

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

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

FDA classification definition

To dilate esophageal strictures with a dilating balloon and electrode sensors.

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