DeviceClearance

Product code OXJ— General, Plastic Surgery

AVANCE® FOAM ABDOMINAL DRESSING KIT

Classification name
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
2
First cleared
Most recent

FDA classification definition

“For reinforcement of soft tissue where weakness exists in abdominal wall defects.”

— U.S. Food and Drug Administration, device classification record for product code OXJ under 21 CFR 878.3300, via openFDA

Market context for product code OXJ

FDA has cleared 2 devices under product code OXJ between 2014 and 2016, filed by 2 applicant companies. 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.

Clearances per year

Top applicants under product code OXJ

Recent clearances under product code OXJ

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