Definition: To Give The Endoscope Channel Additional Or Improved Functionality.
| Device Type ID | 2070 |
| Device Name | Endoscope Channel Accessory |
| Physical State | May Include: Biopsy Cover, Biopsy Cap, External Accessory Channel, Anti Splatter Device, Locking Device, |
| Technical Method | Attach To Endoscope Channel |
| Target Area | Endoscope Channel |
| 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 | ODC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2070 |
| Device | Endoscope Channel Accessory |
| Product Code | ODC |
| 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 | 1 | |
COOK (CANADA), INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILSON COOK MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILSON INSTRUMENTS (SHANGHAI) COMPANY LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Detachment Of Device Or Device Component | 7 |
Device Dislodged Or Dislocated | 5 |
Use Of Device Problem | 3 |
Fluid Leak | 2 |
Device Handling Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operational Issue | 1 |
Device Component Or Accessory | 1 |
| Total Device Problems | 21 |