| Device Type ID | 5641 |
| Device Name | Cannula, Surgical, General & Plastic Surgery |
| 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 | GEA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5641 |
| Device | Cannula, Surgical, General & Plastic Surgery |
| Product Code | GEA |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Surgical Instrument For General Use. |
| CFR Regulation Number | 878.4800 [🔎] |
| Device Problems | |
|---|---|
Break | 54 |
Tear, Rip Or Hole In Device Packaging | 42 |
Adverse Event Without Identified Device Or Use Problem | 19 |
Appropriate Term/Code Not Available | 14 |
Device Markings / Labelling Problem | 6 |
Device Contaminated During Manufacture Or Shipping | 3 |
Device Operates Differently Than Expected | 3 |
Bent | 2 |
Device Dislodged Or Dislocated | 2 |
Material Deformation | 2 |
Physical Resistance / Sticking | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Material Fragmentation | 2 |
Temperature Problem | 2 |
Unsealed Device Packaging | 1 |
Mechanical Jam | 1 |
Device Handling Problem | 1 |
Leak / Splash | 1 |
Loss Of Or Failure To Bond | 1 |
Melted | 1 |
Deformation Due To Compressive Stress | 1 |
Contamination / Decontamination Problem | 1 |
Fracture | 1 |
Material Twisted / Bent | 1 |
Material Integrity Problem | 1 |
| Total Device Problems | 166 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet, Inc. | II | May-26-2016 |
| 2 | MicroAire Surgical Instruments, LLC | II | Apr-05-2016 |