DeviceClearance

Product code OXN— General, Plastic Surgery

Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft

Classification name
Mesh, Surgical, Collagen, Fistula
Device class
Class 2
Regulation
21 CFR 878.3300
Advisory panel
General, Plastic Surgery
Total cleared
1
First cleared
Most recent

FDA classification definition

“For reinforcement of soft tissue where weakness exists during the repair of fistulas.”

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

Market context for product code OXN

FDA has cleared 1 device under product code OXN, all in 2019, 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.

Top applicants under product code OXN

Recent clearances under product code OXN

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