| Device Type ID | 5521 |
| Device Name | Light, Surgical, Accessories |
| 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 | FTA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5521 |
| Device | Light, Surgical, Accessories |
| Product Code | FTA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Lamp. |
| CFR Regulation Number | 878.4580 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KEY SURGICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LITEX MANUFACTURING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICROTEK MEDICAL, INC. AN ECOLAB COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STERIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Component Falling | 4 |
Device Dislodged Or Dislocated | 4 |
Material Integrity Problem | 3 |
Mechanical Problem | 2 |
Defective Device | 1 |
Crack | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Unintended Movement | 1 |
Material Separation | 1 |
| Total Device Problems | 18 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ecolab, Inc. | II | Feb-05-2018 |