FDA product code PGD
Colon Capsule Imaging System
Gastroenterology, Urology·Class 2·21 CFR 876.1330
US regulatory classifications
- US Product Code (FDA)
- PGDView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 876.1330View CFR Regulation →
- Medical specialty
- Gastroenterology, Urology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
visualization of the colon for the detection of polyps
Search keywords
About this record
Colon Capsule Imaging System is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.