PIE · Class II · 21 CFR 876.5980

FDA Product Code PIE: Esophageal Dilator With Balloon And Electrode Sensors

To Dilate Esophageal Strictures With A Dilating Balloon And Electrode Sensors.

Leading manufacturers include Crospon, Ltd..

2
Total
2
Cleared
98d
Avg days
2014
Since

FDA 510(k) Cleared Esophageal Dilator With Balloon And Electrode Sensors Devices (Product Code PIE)

2 devices
1–2 of 2
Cleared Nov 22, 2017
EsoFLIP® ES-310 Balloon Catheter
K172128
Crospon, Ltd.
Gastroenterology & Urology · 131d
Cleared Sep 25, 2014
ESOFLIP ES
K142000
Crospon, Ltd.
Gastroenterology & Urology · 64d

About Product Code PIE - Regulatory Context