DeviceClearance

Product code OXK— General, Plastic Surgery

LTM-LABAROSCOPIC SURGICAL MESH

Classification name
Mesh, Surgical, Collagen, 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 OXK under 21 CFR 878.3300, via openFDA

Market context for product code OXK

FDA has cleared 2 devices under product code OXK between 2012 and 2013, 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.

Clearances per year

Top applicants under product code OXK

Recent clearances under product code OXK

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