OXD · Class II · 21 CFR 878.3300

FDA Product Code OXD: Mesh, Surgical, Non-absorbable, Staple Line Reinforcement

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

Leading manufacturers include W.L. Gore & Associates, Inc..

3
Total
3
Cleared
49d
Avg days
1996
Since

FDA 510(k) Cleared Mesh, Surgical, Non-absorbable, Staple Line Reinforcement Devices (Product Code OXD)

3 devices
1–3 of 3
Cleared May 21, 2001
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K010936
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 54d
Cleared Jul 06, 2000
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K001789
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 23d
Cleared Feb 01, 1996
SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
K955364
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 71d

About Product Code OXD - Regulatory Context