Definition: To Assist In Disinfecting, Rinsing And Storing Endoscopes Or Similar Elongated Instruments.
| Device Type ID | 2528 |
| Device Name | Endoscope Maintenance System |
| Physical State | Wall-mounted Tube For Holding Disinfectant Solution And Endoscope Insertion Tubes And Accessories |
| Technical Method | The Device Consists Of Wall-mounted Vertical Tubes Made Of Clear Seamless PVC That Hold Endoscope Insertion Tubes Or Similar Elongated Instruments And Accessories During Disinfection And Rinsing. After Draining The Solution And Rinse Water, The Tube |
| Target Area | Endoscopes And Disinfectant Solution |
| 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) Exempt |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PUP |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2528 |
| Device | Endoscope Maintenance System |
| Product Code | PUP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |