| Device Type ID | 1879 |
| Device Name | Resectoscope |
| 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 | FJL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1879 |
| Device | Resectoscope |
| Product Code | FJL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Break | 96 |
Material Fragmentation | 44 |
Mechanical Problem | 41 |
Fracture | 40 |
Tip | 36 |
Insulation | 3 |
Detachment Of Device Component | 2 |
Trocar | 1 |
Device Handling Problem | 1 |
Component Falling | 1 |
Bent | 1 |
Device Operates Differently Than Expected | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 268 |