| Device Type ID | 2015 |
| Device Name | System, Imaging, Gastrointestinal, 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 | NEZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2015 |
| Device | System, Imaging, Gastrointestinal, Wireless, Capsule |
| Product Code | NEZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Ingestible Telemetric Gastrointestinal Capsule Imaging System. |
| CFR Regulation Number | 876.1300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CAPSO VISION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GIVEN IMAGING | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
GIVEN IMAGING INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INTROMEDIC CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
OLYMPUS MEDICAL SYSTEMS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Entrapment Of Device | 60 |
Adverse Event Without Identified Device Or Use Problem | 30 |
Unintended Application Program Shut Down | 11 |
Communication Or Transmission Problem | 10 |
Positioning Problem | 10 |
Device Operates Differently Than Expected | 8 |
Appropriate Term/Code Not Available | 7 |
Loss Of Power | 6 |
Insufficient Information | 5 |
Failure To Transmit Record | 5 |
Patient-Device Incompatibility | 5 |
Human-Device Interface Problem | 4 |
Failure To Advance | 3 |
Break | 3 |
Defective Device | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Material Disintegration | 2 |
Device Displays Incorrect Message | 2 |
No Display / Image | 2 |
Use Of Device Problem | 1 |
Signal Artifact | 1 |
Connection Problem | 1 |
Migration Or Expulsion Of Device | 1 |
Difficult To Remove | 1 |
Sparking | 1 |
Missing Test Results | 1 |
Device Operational Issue | 1 |
Data Problem | 1 |
Failure To Adhere Or Bond | 1 |
Device Stops Intermittently | 1 |
Device Or Device Fragments Location Unknown | 1 |
Output Problem | 1 |
No Device Output | 1 |
Computer Software Problem | 1 |
Difficult To Advance | 1 |
Out-Of-Box Failure | 1 |
Mechanical Jam | 1 |
Detachment Of Device Component | 1 |
Poor Quality Image | 1 |
| Total Device Problems | 198 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | IntroMedic Co., Ltd. | II | May-03-2018 |