| Device Type ID | 1812 |
| Device Name | Image, Illumination, Fiberoptic, For Endoscope |
| 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 | FFS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1812 |
| Device | Image, Illumination, Fiberoptic, For Endoscope |
| Product Code | FFS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Overheating Of Device | 2 |
No Device Output | 1 |
Device Emits Odor | 1 |
Device Issue | 1 |
Power Supply | 1 |
Use Of Device Problem | 1 |
| Total Device Problems | 7 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Cook Inc. | II | Jun-05-2017 |