PQI · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4371
Classification
FDA Product Code
PQI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4371
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
A prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.