DeviceClearance

Product code PIJ— General, Plastic Surgery

XenMatrix AB Surgical Graft

Classification name
Collagen Surgical Mesh Containing Drugs
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
3
First cleared
Most recent

FDA classification definition

“Reinforcement of soft tissue where weakness exists.”

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

Market context for product code PIJ

FDA has cleared 3 devices under product code PIJ 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 PIJ

Adverse events under product code PIJ

product code PIJ
Death
4
Total
4

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PIJ

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