| Device Type ID | 5935 |
| Device Name | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| 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 | MGQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5935 |
| Device | Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic |
| Product Code | MGQ |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOPLAX LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HUIZHOU FORYOU MEDICAL DEVICES CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Amerx Health Care Corp. | II | Jun-12-2015 |
| 2 | Amerx Health Care Corp. | II | Dec-04-2014 |
| 3 | Amerx Health Care Corp. | II | Sep-12-2014 |
| 4 | Covidien LLC | II | Mar-27-2017 |
| 5 | Kova Laboratories, Inc. | II | Jul-04-2014 |
| 6 | PhotoMedex, Inc. | II | Apr-23-2015 |