Definition: Phaenicia Sericacta (blow Fly) Larvae Are Harvested And Provided Disinfected For Use In Debriding Non-healing Necrotic Skin And Soft Tissue Wounds, Including Pressure Ulcers, Venous Stasis Ulcers, Neuropathic Foot Ulcers, And Non-healing Traumatic Or
| Device Type ID | 5950 |
| Device Name | Maggots, Medical |
| 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 | NQK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5950 |
| Device | Maggots, Medical |
| Product Code | NQK |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMONDE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |