Definition: This Automated Device Is Intended To Be Used To Clean Endoscopes. Endoscopes That Are Intended To Be Cleaned By The Automated Cleaner System Should Have Been Pre-cleaned And Tested For Leaks And Lumen Obstructions According To The Instrument Manufact
| Device Type ID | 2526 |
| Device Name | Washer, Cleaner, Automated, Endoscope |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Infection Control Devices Branch (INCB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NVE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2526 |
| Device | Washer, Cleaner, Automated, Endoscope |
| Product Code | NVE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Reservoir | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Port | 1 |
Misconnection | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Operational Issue | 1 |
Tube | 1 |
Use Of Incorrect Control Settings | 1 |
Off-Label Use | 1 |
Temperature Problem | 1 |
| Total Device Problems | 12 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Custom Ultrasonics, Inc. | II | Jul-06-2016 |