| Device Type ID | 1760 |
| Device Name | Light Source, Fiberoptic, Routine |
| 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 | FCW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 1760 |
| Device | Light Source, Fiberoptic, Routine |
| Product Code | FCW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
NOVAPROBE INCORPORATED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Thermal Decomposition Of Device | 32 |
Smoking | 31 |
Overheating Of Device | 23 |
Melted | 19 |
Device Emits Odor | 17 |
Temperature Problem | 16 |
Fire | 15 |
Power Problem | 8 |
Electrical /Electronic Property Problem | 6 |
Sparking | 5 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Device Dislodged Or Dislocated | 4 |
Failure To Power Up | 3 |
Hole In Material | 2 |
Device-Device Incompatibility | 2 |
Insufficient Information | 2 |
Noise, Audible | 2 |
Device Operates Differently Than Expected | 2 |
Device Inoperable | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
Device Sensing Problem | 1 |
Material Discolored | 1 |
Cable | 1 |
Material Disintegration | 1 |
Inadequate Lighting | 1 |
Appropriate Term/Code Not Available | 1 |
Obstruction Of Flow | 1 |
Split | 1 |
Failure To Shut Off | 1 |
Break | 1 |
Loose Or Intermittent Connection | 1 |
Ambient Noise Problem | 1 |
Electrical Shorting | 1 |
Optical Problem | 1 |
Excessive Heating | 1 |
Arcing | 1 |
Environmental Particulates | 1 |
Intermittent Loss Of Power | 1 |
| Total Device Problems | 214 |