| Device Type ID | 5519 |
| Device Name | Light, Surgical, Ceiling Mounted |
| 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 | FSY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5519 |
| Device | Light, Surgical, Ceiling Mounted |
| Product Code | FSY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Lamp. |
| CFR Regulation Number | 878.4580 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CONVIDA HEALTHCARE & SYSTEMS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DICKSON & DICKSON HEALTHCARE (US), INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DR. MACH GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDICAL ILLUMINATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDICAL ILLUMINATION INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUNNEX, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
UMBEL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Detachment Of Device Component | 131 |
Component Falling | 110 |
Detachment Of Device Or Device Component | 62 |
Material Integrity Problem | 52 |
Flaked | 46 |
Mechanical Problem | 44 |
Device Dislodged Or Dislocated | 39 |
Device Issue | 38 |
Material Separation | 29 |
Degraded | 29 |
Physical Property Issue | 29 |
Component Missing | 22 |
Use Of Device Problem | 20 |
Material Disintegration | 17 |
Device Operates Differently Than Expected | 14 |
Crack | 13 |
Corroded | 12 |
Maintenance Does Not Comply To Manufacturers Recommendations | 9 |
Misassembled | 9 |
Pitted | 8 |
Device Maintenance Issue | 7 |
Break | 5 |
Fire | 5 |
Facilities Issue | 5 |
Metal Shedding Debris | 5 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Improper Or Incorrect Procedure Or Method | 4 |
Energy Output Problem | 4 |
Fracture | 4 |
Labelling, Instructions For Use Or Training Problem | 4 |
Material Erosion | 4 |
Material Fragmentation | 4 |
Material Deformation | 3 |
Loose Or Intermittent Connection | 3 |
Positioning Problem | 3 |
Temperature Problem | 3 |
Difficult To Position | 2 |
Insufficient Information | 2 |
Unstable | 2 |
Device Fell | 1 |
Failure To Osseointegrate | 1 |
Weld | 1 |
Electrical /Electronic Property Problem | 1 |
Disassembly | 1 |
Inadequate Lighting | 1 |
Torn Material | 1 |
Overheating Of Device | 1 |
Misassembly During Maintenance / Repair | 1 |
Disconnection | 1 |
Unintended Movement | 1 |
Cover | 1 |
Device Damaged By Another Device | 1 |
Installation-Related Problem | 1 |
| Total Device Problems | 820 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beaver-Visitec International Inc. | II | Jun-15-2015 |
| 2 | Centurion Medical Products Corporation | II | Jul-20-2016 |
| 3 | Covidien LLC | II | Jul-20-2015 |
| 4 | GETINGE US SALES LLC | II | Mar-07-2019 |
| 5 | GETINGE US SALES LLC | II | Apr-10-2018 |
| 6 | GETINGE US SALES LLC | II | Mar-05-2018 |
| 7 | Maquet Cardiovascular Us Sales, Llc | II | Jul-07-2015 |
| 8 | Maquet Medical Systems USA | II | Jun-06-2014 |
| 9 | Resource Optimization & Innovation Llc | II | Oct-07-2015 |
| 10 | Steris Corporation | II | Jun-23-2014 |
| 11 | Stryker Communications | II | Mar-01-2018 |
| 12 | Stryker Communications | II | Feb-23-2018 |
| 13 | Stryker Communications | II | Mar-10-2017 |
| 14 | Trumpf Medical Systems, Inc. | II | Dec-31-2015 |
| 15 | Trumpf Medical Systems, Inc. | II | Aug-07-2015 |
| 16 | Windstone Medical Packaging, Inc. | II | Apr-11-2017 |
| 17 | Windstone Medical Packaging, Inc. | II | Feb-28-2017 |
| 18 | Windstone Medical Packaging, Inc. | II | Oct-20-2016 |