OEI · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4780
Classification
FDA Product Code
OEI
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
A tubular drain made from silicone or similar material and is coated with a silver containing material and is intended to drain fluids from body cavities using gravity drainage or attached to a suction pump.