| Device Type ID | 5500 |
| Device Name | Cannula, Injection |
| Regulation Description | Introduction/drainage Catheter And Accessories. |
| 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 Two - Surgical (GSDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4200 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | FGY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5500 |
| Device | Mesh, Surgical, Metal |
| Product Code | EZX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.4200 [🔎] |
| Device Problems | |
|---|---|
Migration | 5 |
Migration Or Expulsion Of Device | 5 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Incorrect Device Or Component Shipped | 2 |
Packaging Problem | 2 |
Torn Material | 2 |
Break | 1 |
Stretched | 1 |
Unintended Movement | 1 |
Leak / Splash | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 24 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Synthes (USA) Products LLC | II | Oct-30-2015 |