| Device Type ID | 5756 |
| Device Name | Gauze / Sponge,nonresorbable For External Use |
| Regulation Description | Nonresorbable Gauze/sponge For External Use. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4014 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NAB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5756 |
| Device | Gauze / Sponge,nonresorbable For External Use |
| Product Code | NAB |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Nonresorbable Gauze/sponge For External Use. |
| CFR Regulation Number | 878.4014 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 15 |
Material Separation | 6 |
Material Fragmentation | 3 |
Failure To Obtain Sample | 3 |
Incomplete Or Missing Packaging | 2 |
Material Frayed | 2 |
Delivered As Unsterile Product | 1 |
Component Missing | 1 |
Migration Or Expulsion Of Device | 1 |
Material Deformation | 1 |
Sticking | 1 |
Insufficient Information | 1 |
| Total Device Problems | 37 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ASO, LLC | II | Nov-30-2018 |
| 2 | Cardinal Health 200, LLC | II | Feb-26-2019 |
| 3 | Revmedx Inc | II | Sep-11-2015 |