Colon Capsule Imaging System
The Colon Capsule Imaging System is a swallowable capsule endoscopy device used for visualization of the colon to detect polyps, providing a non-invasive alternative to traditional colonoscopy. It is an FDA Class 2 device regulated under 21 CFR 876.1330, requiring 510(k) premarket notification, within the Gastroenterology and Urology (GU) medical specialty. The product code is PGD. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PGD
- Device Class
- FDA class 2
- Regulation Number
- 876.1330
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
visualization of the colon for the detection of polyps
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.