PGD · Class II · 21 CFR 876.1330

FDA Product Code PGD: Colon Capsule Imaging System

Visualization Of The Colon For The Detection Of Polyps

Leading manufacturers include Given Imaging , Ltd..

2
Total
1
Cleared
235d
Avg days
2014
Since

FDA 510(k) Cleared Colon Capsule Imaging System Devices (Product Code PGD)

2 devices
1–2 of 2
Cleared Jan 14, 2016
PillCam COLON 2 Capsule Endoscopy System
K153466
Given Imaging , Ltd.
Gastroenterology & Urology · 44d
Not Cleared Jan 29, 2014
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM
DEN120023
Given Imaging , Ltd.
Gastroenterology & Urology · 426d

About Product Code PGD - Regulatory Context