DeviceClearance

Product code OXC— General, Plastic Surgery

ECHELON ENDOPATH Staple Line Reinforcement

Classification name
Mesh, Surgical, Absorbable, Staple Line Reinforcement
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
9
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 OXC under 21 CFR 878.3300, via openFDA

Market context for product code OXC

FDA has cleared 9 devices under product code OXC between 2013 and 2026, 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 OXC

Recent clearances under product code OXC

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