OXN · Class II · 21 CFR 878.3300

FDA Product Code OXN: Mesh, Surgical, Collagen, Fistula

For Reinforcement Of Soft Tissue Where Weakness Exists During The Repair Of Fistulas.

Leading manufacturers include Cook Biotech Incorporated.

1
Total
1
Cleared
185d
Avg days
2019
Since

FDA 510(k) Cleared Mesh, Surgical, Collagen, Fistula Devices (Product Code OXN)

1 devices
1–1 of 1
Cleared Dec 27, 2019
Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft
K191696
Cook Biotech Incorporated
General & Plastic Surgery · 185d

About Product Code OXN - Regulatory Context