| Device Type ID | 1939 |
| Device Name | Light Source, Endoscope, Xenon Arc |
| 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) Exempt |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GCT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1939 |
| Device | Light Source, Endoscope, Xenon Arc |
| Product Code | GCT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 9 |
Adverse Event Without Identified Device Or Use Problem | 7 |
Smoking | 3 |
Fire | 2 |
Poor Quality Image | 2 |
Device Handling Problem | 2 |
Off-Label Use | 1 |
Old To Be Deactivated | 1 |
Erratic Or Intermittent Display | 1 |
Microbial Contamination Of Device | 1 |
Insufficient Information | 1 |
Sparking | 1 |
Device Component Or Accessory | 1 |
Device Inoperable | 1 |
Power Problem | 1 |
Inadequate Lighting | 1 |
Endoscope | 1 |
Device Displays Incorrect Message | 1 |
Contamination / Decontamination Problem | 1 |
| Total Device Problems | 38 |