OXE · Class II · 21 CFR 878.3300

FDA Product Code OXE: Mesh, Surgical, Collagen, Staple Line Reinforcement

For Reinforcement Of Soft Tissue Where Weakness Exists During Staple Line Reinforcement Procedures.

Leading manufacturers include Cook Biotech, Inc., Kerecis Limited and Cook Biotech Incorporated.

4
Total
4
Cleared
99d
Avg days
2002
Since

FDA 510(k) Cleared Mesh, Surgical, Collagen, Staple Line Reinforcement Devices (Product Code OXE)

4 devices
1–4 of 4
Cleared Apr 28, 2017
Biodesign Staple Line Reinforcement
K170945
Cook Biotech Incorporated
General & Plastic Surgery · 29d
Cleared Aug 19, 2016
Kerecis SecureMesh
K153364
Kerecis Limited
General & Plastic Surgery · 273d
Cleared Aug 23, 2002
SURGISIS STAPLE LINE REINFORCEMENT
K022044
Cook Biotech, Inc.
General & Plastic Surgery · 60d

About Product Code OXE - Regulatory Context