OMP · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4780
Classification
FDA Product Code
OMP
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4780
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.