| Device Type ID | 5939 |
| Device Name | Sizer, Mammary, Breast Implant Volume |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | MRD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5939 |
| Device | Sizer, Mammary, Breast Implant Volume |
| Product Code | MRD |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 15 |
Break | 14 |
Material Rupture | 7 |
Improper Or Incorrect Procedure Or Method | 4 |
Patient-Device Incompatibility | 3 |
Off-Label Use | 3 |
Unsealed Device Packaging | 1 |
Malposition Of Device | 1 |
Device Expiration Issue | 1 |
Delivered As Unsterile Product | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Material Puncture / Hole | 1 |
Use Of Device Problem | 1 |
No Apparent Adverse Event | 1 |
| Total Device Problems | 54 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Allergan Inc | II | Jul-07-2015 |
| 2 | Mentor Texas, LP. | II | Jan-13-2015 |
| 3 | Mentor Texas, LP. | II | Sep-04-2014 |