Device Type ID | 5508 |
Device Name | Lamp, Operating-room |
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) Exempt |
CFR Regulation Number | 878.4580 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | FQP |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Eligible For Accredited Persons Program |
Device Type ID | 5508 |
Device | Lamp, Operating-room |
Product Code | FQP |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Surgical Lamp. |
CFR Regulation Number | 878.4580 [🔎] |
Device Problems | |
---|---|
Device Issue | 13 |
Component Falling | 13 |
Flaked | 6 |
Material Integrity Problem | 6 |
Degraded | 6 |
Mechanical Problem | 3 |
Detachment Of Device Or Device Component | 3 |
Use Of Device Problem | 2 |
Device Dislodged Or Dislocated | 2 |
Physical Property Issue | 2 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Component Missing | 1 |
Facilities Issue | 1 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
Torn Material | 1 |
Detachment Of Device Component | 1 |
Device Maintenance Issue | 1 |
Fitting Problem | 1 |
Device-Device Incompatibility | 1 |
Total Device Problems | 66 |