OXF · Class II · 21 CFR 878.3300

FDA Product Code OXF: Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery

For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.

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

8
Total
8
Cleared
139d
Avg days
2013
Since
Stable submission activity - 2 submissions in the last 2 years
Consistent review times: 138d avg (recent)

FDA 510(k) Cleared Mesh, Surgical, Absorbable, Plastic And Reconstructive Surgery Devices (Product Code OXF)

8 devices
1–8 of 8
Cleared Jun 20, 2025
Restrata Soft Tissue Reinforcement (STR)
K251224
Acera Surgical, Inc.
General & Plastic Surgery · 60d
Cleared May 21, 2025
3DMatrix DynaFlex (DynaFlex)
K243302
Printbio, Inc.
General & Plastic Surgery · 215d
Cleared May 23, 2024
3DMatrix Surgical Mesh
K232602
Printbio, Inc.
General & Plastic Surgery · 269d
Cleared Dec 19, 2022
GORE® ENFORM Biomaterial
K222919
W. L. Gore and Associates, Inc.
General & Plastic Surgery · 84d
Cleared Apr 05, 2018
GORE ENFORM Biomaterial
K173333
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 164d
Cleared Feb 10, 2017
GORE BIO-A Tissue Reinforcement
K163217
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 86d

About Product Code OXF - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code OXF since 2013, with 8 receiving FDA clearance (average review time: 139 days).

Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.

FDA 510(k) Review Time - OXF Product Code

FDA review times for OXF submissions have been consistent, averaging 138 days recently vs 139 days historically.

OXF devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →