PGD
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Colon Capsule Imaging System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1330
- Medical specialty
- Gastroenterology, Urology
- FDA definition
- visualization of the colon for the detection of polyps
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| PillCam COLON 2 Capsule Endoscopy System (K153466) | Given Imaging , Ltd. | 2016-01-14 |
| GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY SYSTEM (DEN120023) | Given Imaging , Ltd. | 2014-01-29 |
Track PGD automatically
Every clearance here is in the API, with alerts when new ones post.