Definition: Used To Provide Access, Illumination, And Allow Observation Or Manipulation Of Body Cavities, Hollow Organs, And Canals
| Device Type ID | 2045 |
| Device Name | Led Light Source |
| 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 | NTN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2045 |
| Device | Led Light Source |
| Product Code | NTN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Endoscope And Accessories. |
| CFR Regulation Number | 876.1500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
OLYMPUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OLYMPUS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUEST MEDICAL IMAGING | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Erratic Or Intermittent Display | 1 |
Overheating Of Device | 1 |
| Total Device Problems | 2 |