FDA Product Code OWT: Mesh, Surgical, Absorbable, Abdominal Hernia
For Reinforcement Of Soft Tissue Where Weakness Exists During Hernia Repair.
Leading manufacturers include C.R. Bard, Inc., Novus Scientific AB and W.L. Gore & Associates, Inc..
11
Total
11
Cleared
155d
Avg days
2003
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
132d
recently vs 157d historically
FDA 510(k) Cleared Mesh, Surgical, Absorbable, Abdominal Hernia Devices (Product Code OWT)
11 devices
Cleared
Feb 19, 2025
Phasix ST Umbilical Hernia Patch
Davol, Inc., A Subsidiary of C.R. Bard, Inc.
General & Plastic Surgery
132d
Cleared
Feb 13, 2024
Transorb™ Self-Gripping Resorbable Mesh
Sofradim Production
General & Plastic Surgery
90d
Cleared
Mar 26, 2020
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
Novus Scientific AB
General & Plastic Surgery
269d
Cleared
Jul 31, 2019
GORE BIO-A Tissue Reinforcement
W.L. Gore & Associates, Inc.
General & Plastic Surgery
29d
Cleared
Jun 12, 2019
Phasix ST Mesh with Open Positioning System
C.R. Bard, Inc.
General & Plastic Surgery
131d
Cleared
Apr 25, 2018
Phasix ST Mesh
C.R. Bard, Inc.
General & Plastic Surgery
208d
Cleared
Jun 05, 2015
Phasix ST Mesh
C.R. Bard, Inc.
General & Plastic Surgery
192d
Cleared
Oct 22, 2012
PHASIX PLUG AND PATCH
C.R. Bard, Inc.
General & Plastic Surgery
227d
About Product Code OWT - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code OWT since 2003, with 11 receiving FDA clearance (average review time: 155 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - OWT Product Code
Recent submissions under OWT have taken an average of 132 days to reach a decision - down from 157 days historically, suggesting improved FDA processing for this classification.
OWT devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →