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PGD — Colon Capsule Imaging System Class II

FDA Device Classification

Classification Details

Product Code
PGD
Device Class
Class II
Regulation Number
876.1330
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

visualization of the colon for the detection of polyps

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K153466given imagingPillCam COLON 2 Capsule Endoscopy SystemJanuary 14, 2016
DEN120023given imagingGIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEMJanuary 29, 2014