PGD

Colon Capsule Imaging System

Product code: PGD
Device name: Colon Capsule Imaging System
Device class: Class 2
21 CFR: 21 CFR 876.1330
Medical specialty: Gastroenterology, Urology
Marketing pathway: 510(K)
510(k) clearances (all years, FDA): 2 (all years; only the last 3 years are listed here)

FDA classification definition

visualization of the colon for the detection of polyps

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

Official FDA classification page: PGD

Classification and pathway per current FDA publications. Data from openFDA (CC0).