Device Type ID | 5516 |
Device Name | Light, Surgical, Fiberoptic |
Regulation Description | Surgical Lamp. |
Regulation Medical Specialty | General & Plastic Surgery |
Review Panel | General & Plastic Surgery |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch One - Light Based/Laser (GSDB1) |
Submission Type | 510(k) |
CFR Regulation Number | 878.4580 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | FST |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 5516 |
Device | Light, Surgical, Fiberoptic |
Product Code | FST |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Surgical Lamp. |
CFR Regulation Number | 878.4580 [🔎] |
Premarket Reviews | ||
---|---|---|
Manufacturer | Decision | |
ENROXTECH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 |
Device Problems | |
---|---|
Thermal Decomposition Of Device | 8 |
Temperature Problem | 7 |
Overheating Of Device | 5 |
Use Of Device Problem | 4 |
Melted | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Cannula | 1 |
Electrical /Electronic Property Problem | 1 |
Smoking | 1 |
Device Dislodged Or Dislocated | 1 |
Power Problem | 1 |
Fire | 1 |
Fracture | 1 |
Device Operates Differently Than Expected | 1 |
Break | 1 |
Insufficient Information | 1 |
Detachment Of Device Component | 1 |
Material Separation | 1 |
Device Handling Problem | 1 |
Total Device Problems | 41 |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | Steris Corporation | II | Jan-07-2015 |