DeviceClearance

Product code OXE— General, Plastic Surgery

Biodesign Staple Line Reinforcement

Classification name
Mesh, Surgical, Collagen, Staple Line Reinforcement
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
4
First cleared
Most recent

FDA classification definition

“For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.”

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

Market context for product code OXE

FDA has cleared 4 devices under product code OXE between 2002 and 2017, filed by 4 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 OXE

Recent clearances under product code OXE

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