| Device Type ID | 1815 |
| Device Name | System, Gastrointestinal Motility (electrical) |
| Regulation Description | Gastrointestinal Motility Monitoring 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 | 876.1725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FFX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1815 |
| Device | System, Gastrointestinal Motility (electrical) |
| Product Code | FFX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Gastrointestinal Motility Monitoring System. |
| CFR Regulation Number | 876.1725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
COOK (CANADA), INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CROSPON LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
GIVEN IMAGING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GIVEN IMAGING INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
H & A MUI ENTERPRISES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Difficult To Remove | 12 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Patient-Device Incompatibility | 4 |
Device Operates Differently Than Expected | 4 |
Device Damaged Prior To Use | 4 |
Entrapment Of Device | 2 |
Break | 1 |
Crack | 1 |
Torn Material | 1 |
Material Deformation | 1 |
Problem With Removal Of Enzymatic Cleaner | 1 |
Loss Of Or Failure To Bond | 1 |
Failure To Calibrate | 1 |
| Total Device Problems | 38 |