| Device Type ID | 1791 |
| Device Name | Pump, Air, Non-manual, For Endoscope |
| Regulation Description | Endoscope And Accessories. |
| 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) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FEQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1791 |
| Device | Pump, Air, Non-manual, For Endoscope |
| Product Code | FEQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ERBE ELEKTROMEDIZIN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ERBE USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Reflux Within Device | 8 |
Connector | 2 |
Adapter (Adaptor) | 1 |
Fluid Leak | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Protective Measures Problem | 1 |
Device Contamination With Body Fluid | 1 |
Device Component Or Accessory | 1 |
| Total Device Problems | 16 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Olympus Corporation Of The Americas | II | Oct-08-2015 |