Definition: High Level Disinfection Of Reusable, Heat-sensitive Devices If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 FR 26807, Available At Https:
| Device Type ID | 2527 |
| Device Name | Accessories, Germicide, Cleaning, For Endoscopes |
| Physical State | High Level Disinfection Of Reusable, Heat-sensitive Devices |
| Technical Method | High Level Disinfection Of Reusable, Heat-sensitive Devices |
| Target Area | High Level Disinfection Of Reusable, Heat-sensitive Devices |
| 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 | NZA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2527 |
| Device | Accessories, Germicide, Cleaning, For Endoscopes |
| Product Code | NZA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 1 |