OWT · Class II · 21 CFR 878.3300

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., W.L. Gore & Associates, Inc. and Novus Scientific AB.

13
Total
13
Cleared
149d
Avg days
2003
Since
Growing category - 3 submissions in the last 2 years vs 1 in the prior period
Review times improving: avg 122d recently vs 157d historically

FDA 510(k) Cleared Mesh, Surgical, Absorbable, Abdominal Hernia Devices (Product Code OWT)

13 devices
1–13 of 13
Cleared Oct 16, 2026
Transorb™ Self-Gripping Resorbable Mesh (TSB1510 / TSB2020 / TSB3030 / TSB4030)
K262443
Sofradim Production
General & Plastic Surgery · 92d
Cleared Sep 28, 2026
Phasix ST Parastomal Hernia Mesh
K261543
Davol, Inc., A Subsidiary of C.R. Bard, Inc.
General & Plastic Surgery · 143d
Cleared Feb 19, 2025
Phasix ST Umbilical Hernia Patch
K243241
Davol, Inc., A Subsidiary of C.R. Bard, Inc.
General & Plastic Surgery · 132d
Cleared Feb 13, 2024
Transorb™ Self-Gripping Resorbable Mesh
K233661
Sofradim Production
General & Plastic Surgery · 90d
Cleared Mar 26, 2020
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
K191749
Novus Scientific AB
General & Plastic Surgery · 269d
Cleared Jul 31, 2019
GORE BIO-A Tissue Reinforcement
K191773
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 29d
Cleared Jun 12, 2019
Phasix ST Mesh with Open Positioning System
K190185
C.R. Bard, Inc.
General & Plastic Surgery · 131d
Cleared Apr 25, 2018
Phasix ST Mesh
K173143
C.R. Bard, Inc.
General & Plastic Surgery · 208d
Cleared Jul 27, 2017
TIGR Matrix Surgical Mesh
K163005
Novus Scientific AB
General & Plastic Surgery · 272d
Cleared Jun 05, 2015
Phasix ST Mesh
K143380
C.R. Bard, Inc.
General & Plastic Surgery · 192d
Cleared Oct 22, 2012
PHASIX PLUG AND PATCH
K120728
C.R. Bard, Inc.
General & Plastic Surgery · 227d
Cleared Aug 30, 2010
TEPHAFLEX COMPOSITE MESH
K101287
Tepha, Inc.
General & Plastic Surgery · 115d
Cleared Dec 31, 2003
GORE BIOABSORBABLE MESH
K033671
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 37d

About Product Code OWT - Regulatory Context

510(k) Submission Activity

13 total 510(k) submissions under product code OWT since 2003, with 13 receiving FDA clearance (average review time: 149 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - OWT Product Code

Recent submissions under OWT have taken an average of 122 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 →