PID

Esophageal Dilator Balloon With Or Without Electrode Sensors

Product code

PID

Device name

Esophageal Dilator Balloon With Or Without 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)

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

FDA classification definition

To dilate the lower esophageal sphincter of patients with Achalasia.

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