Definition: THE CAPSULE IS A DISPOSABLE, INGESTIBLE CAPSULE DESIGNED TO ACQUIRE VIDEO IMAGES OF THE ESOPHAGUS. THE CAPSULE TRANSMITS THE ACQUIRED IMAGES VIA RF COMMUNICATION CHANNEL TO A DATA RECORDER LOCATED OUTSIDE THE BODY. THE DIAGNOSTIC IMAGING SYSTEM IS IN
| Device Type ID | 2044 |
| Device Name | System, Imaging, Esophageal, Wireless, Capsule |
| Regulation Description | Ingestible Telemetric Gastrointestinal Capsule Imaging 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 | 876.1300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NSI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2044 |
| Device | System, Imaging, Esophageal, Wireless, Capsule |
| Product Code | NSI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ingestible Telemetric Gastrointestinal Capsule Imaging System. |
| CFR Regulation Number | 876.1300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
GIVEN IMAGING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GIVEN IMAGING INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Entrapment Of Device | 6 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Material Fragmentation | 2 |
Device Operates Differently Than Expected | 1 |
Human-Device Interface Problem | 1 |
| Total Device Problems | 13 |