OEI — Drainage Catheter With Antibiotic Class II

FDA Device Classification

Classification Details

Product Code
OEI
Device Class
Class II
Regulation Number
878.4780
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K063245bacterin internationalELUTIA COATED CLOSED SURGICAL WOUND DRAINNovember 28, 2007