PID · Class II · 21 CFR 876.5980

FDA Product Code PID: Esophageal Dilator Balloon With Or Without Electrode Sensors

To Dilate The Lower Esophageal Sphincter Of Patients With Achalasia.

Leading manufacturers include Boston Scientific Corp and Wilson-Cook Medical, Inc..

3
Total
3
Cleared
71d
Avg days
2005
Since

FDA 510(k) Cleared Esophageal Dilator Balloon With Or Without Electrode Sensors Devices (Product Code PID)

3 devices
1–3 of 3
Cleared Jan 25, 2019
Wilson-Cook Achalasia Balloon
K182895
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 102d
Cleared Mar 11, 2005
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
K050232
Boston Scientific Corp
Gastroenterology & Urology · 38d

About Product Code PID - Regulatory Context