| Device Type ID | 1766 |
| Device Name | Resectoscope, Working Element |
| 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 | FDC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1766 |
| Device | Resectoscope, Working Element |
| Product Code | FDC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Break | 11 |
Material Fragmentation | 7 |
Sparking | 7 |
Electrical /Electronic Property Problem | 4 |
Electrode | 4 |
Unintended Power Up | 3 |
Inappropriate Shock | 3 |
Temperature Problem | 3 |
Grounding Malfunction | 3 |
Device Stops Intermittently | 2 |
Inadequate Service | 2 |
Tip | 2 |
Degraded | 1 |
Use Of Device Problem | 1 |
Arcing Of Electrodes | 1 |
Component Missing | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Material Discolored | 1 |
Failure To Service | 1 |
Device Operates Differently Than Expected | 1 |
Fire | 1 |
Fracture | 1 |
Device Disinfection Or Sterilization Issue | 1 |
Thermal Decomposition Of Device | 1 |
Insufficient Information | 1 |
Mechanical Problem | 1 |
Output Problem | 1 |
Device Issue | 1 |
Device Damaged By Another Device | 1 |
Device Handling Problem | 1 |
Therapy Delivered To Incorrect Body Area | 1 |
| Total Device Problems | 70 |