| Device Type ID | 5727 |
| Device Name | Tray, Surgical |
| Regulation Description | Manual Surgical Instrument For General Use. |
| 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 | 878.4800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | LRP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5727 |
| Device | Tray, Surgical |
| Product Code | LRP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Occlusion Within Device | 1 |
Unintended Ejection | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Misassembly By Users | 1 |
Difficult To Advance | 1 |
Fluid Leak | 1 |
| Total Device Problems | 8 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | B. Braun Medical, Inc. | II | Nov-01-2016 |
| 2 | Cardinal Health 200, LLC | II | Jul-18-2018 |
| 3 | Centurion Medical Products Corporation | II | Mar-17-2018 |