OWT

Mesh, Surgical, Absorbable, Abdominal Hernia

Product code
OWT
Device name
Mesh, Surgical, Absorbable, Abdominal Hernia
Device class
Class 2
21 CFR
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
11

FDA classification definition

For reinforcement of soft tissue where weakness exists during hernia repair.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2025-02-19.

NumberDecision dateApplicantDevice nameSummary
K2432412025-02-19Davol, Inc., A Subsidiary of C.R. BardPhasix ST Umbilical Hernia PatchPDF
K2336612024-02-13Sofradim ProductionTransorb™ Self-Gripping Resorbable MeshPDF

2 summaries are archived here for direct download.

Official FDA classification page: OWT
Classification and pathway per current FDA publications. Data from openFDA (CC0).