| Device Type ID | 1759 |
| Device Name | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Regulation Description | Fiberoptic Light Ureteral Catheter. |
| 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) Exempt |
| CFR Regulation Number | 876.4020 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | FCS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 1759 |
| Device | Light, Catheter, Fiberoptic, Glass, Ureteral |
| Product Code | FCS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Fiberoptic Light Ureteral Catheter. |
| CFR Regulation Number | 876.4020 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Overheating Of Device | 8 |
Melted | 7 |
Smoking | 3 |
Use Of Device Problem | 1 |
Catheter | 1 |
Material Separation | 1 |
| Total Device Problems | 21 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | Apr-19-2017 |