| Device Type ID | 5917 |
| Device Name | Gauze/sponge, Internal |
| 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 | EFQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5917 |
| Device | Gauze/sponge, Internal |
| Product Code | EFQ |
| Device Problems | |
|---|---|
Material Integrity Problem | 10 |
Material Fragmentation | 7 |
Device Operates Differently Than Expected | 6 |
Product Quality Problem | 5 |
Material Frayed | 4 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Break | 4 |
Torn Material | 3 |
Incomplete Or Missing Packaging | 3 |
Detachment Of Device Component | 3 |
Component Missing | 2 |
Material Disintegration | 2 |
Appropriate Term/Code Not Available | 1 |
Pad | 1 |
Invalid Sensing | 1 |
Decreased Sensitivity | 1 |
Failure To Obtain Sample | 1 |
Tube | 1 |
Unsealed Device Packaging | 1 |
Missing Value Reason | 1 |
Nonstandard Device | 1 |
Packaging Problem | 1 |
Flaked | 1 |
| Total Device Problems | 64 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | American Surgical Company | II | May-26-2016 |
| 2 | Customed, Inc | II | Sep-03-2015 |