DeviceClearance

Product code OEI— General, Plastic Surgery

ELUTIA COATED CLOSED SURGICAL WOUND DRAIN

Classification name
Drainage Catheter With Antibiotic
Device class
Class 2
Regulation
21 CFR 878.4780
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code OEI under 21 CFR 878.4780, via openFDA

Market context for product code OEI

FDA has cleared 1 device under product code OEI, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OEI

Recent clearances under product code OEI

Data sourced from openFDA. This site is unofficial and independent of the FDA.