| Device Type ID | 1769 |
| Device Name | Retractor, Fiberoptic |
| Regulation Description | Gastroenterology-urology Fiberoptic Retractor. |
| 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) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 876.4530 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FDG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1769 |
| Device | Retractor, Fiberoptic |
| Product Code | FDG |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Gastroenterology-urology Fiberoptic Retractor. |
| CFR Regulation Number | 876.4530 [🔎] |
| Device Problems | |
|---|---|
Hinge | 1 |
Component Falling | 1 |
Break | 1 |
Device Operates Differently Than Expected | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 5 |