Definition: Visualization Of The Colon For The Detection Of Polyps
| Device Type ID | 2092 |
| Device Name | Colon Capsule Imaging System |
| Physical State | Capsule |
| Technical Method | The Device Is A Single-use Ingestible Capsule Designed To Acquire Video Images During Natural Propulsion Through The Digestive System. It Is Specifically Designed To Visualize The Complex Anatomy Of The Colon |
| Target Area | Colon |
| Regulation Description | Colon Capsule Endoscopy System. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1330 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PGD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2092 |
| Device | Colon Capsule Imaging System |
| Product Code | PGD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Colon Capsule Endoscopy System. |
| CFR Regulation Number | 876.1330 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GIVEN IMAGING | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
GIVEN IMAGING INC. | ||
GRANTED | 1 | |
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 2 |
| Total Device Problems | 2 |