Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Colon Capsule Imaging System

FDA product code PGD · 1 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.1330
Review panel
GU
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2016-01-14 – 2016-01-14

visualization of the colon for the detection of polyps

↑