| Device Type ID | 5759 |
| Device Name | Dressing, Wound, Hydrogel Without Drug And/or Biologic |
| Regulation Description | Hydrogel Wound Dressing And Burn Dressing. |
| 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 | 878.4022 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | NAE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5759 |
| Device | Dressing, Wound, Hydrogel Without Drug And/or Biologic |
| Product Code | NAE |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Hydrogel Wound Dressing And Burn Dressing. |
| CFR Regulation Number | 878.4022 [🔎] |
| Device Problems | |
|---|---|
Device Contamination With Chemical Or Other Material | 5 |
Delivered As Unsterile Product | 5 |
Adverse Event Without Identified Device Or Use Problem | 4 |
Unsealed Device Packaging | 4 |
Device Packaging Compromised | 2 |
Packaging Problem | 2 |
Tear, Rip Or Hole In Device Packaging | 2 |
Increased Sensitivity | 1 |
Product Quality Problem | 1 |
Fracture | 1 |
Use Of Device Problem | 1 |
Split | 1 |
Hole In Material | 1 |
Incomplete Or Missing Packaging | 1 |
| Total Device Problems | 31 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | O-Two Medical Technologies, Inc. | II | Jun-22-2017 |
| 2 | Safe N Simple, LLC | II | Nov-07-2018 |