| Device Type ID | 4131 |
| Device Name | Endoilluminator |
| Regulation Description | Endoscope And Accessories. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Diagnostic And Surgical Devices Branch (DSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.1500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MPA |
| 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 | 4131 |
| Device | Endoilluminator |
| Product Code | MPA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PEREGRINE SURGICAL LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
System | 7 |
Appropriate Term/Code Not Available | 5 |
Delivered As Unsterile Product | 3 |
Unsealed Device Packaging | 3 |
Loss Of Power | 3 |
Device Displays Incorrect Message | 2 |
Device Operates Differently Than Expected | 2 |
Operating System Becomes Nonfunctional | 2 |
Device Operational Issue | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Fiberoptic | 1 |
Electrical /Electronic Property Problem | 1 |
Physical Property Issue | 1 |
Material Separation | 1 |
Material Fragmentation | 1 |
Break | 1 |
| Total Device Problems | 35 |