OKO · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4683
Classification
FDA Product Code
OKO
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4683
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A non-powered suction apparatus indicated for negative pressure wound therapy (npwt) that is intended 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.