FDA Product Code OXH: Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
For Reinforcement Of Soft Tissue Where Weakness Exists In Plastic And Reconstructive Surgery.
Leading manufacturers include Kerecis Limited, Miromatrix Medical, Inc. and Integra Lifesciences Corporation (Owner of Tei Biosciences).
5
Total
5
Cleared
103d
Avg days
2015
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times improving: avg
29d
recently vs 122d historically
FDA 510(k) Cleared Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery Devices (Product Code OXH)
5 devices
Cleared
Jul 15, 2025
Kerecis SurgiBind (50241)
Kerecis Limited
General & Plastic Surgery
29d
Cleared
May 02, 2021
Kerecis Reconstruct
Kerecis Limited
General & Plastic Surgery
250d
Cleared
Jun 07, 2017
SurgiMend PRS Meshed, Revize-X
Integra Lifesciences Corporation (Owner of Tei Biosciences)
General & Plastic Surgery
29d
Cleared
Jun 08, 2016
Miromatrix Biological Mesh
Miromatrix Medical, Inc.
General & Plastic Surgery
117d
Cleared
May 12, 2015
Miromatrix Biological Mesh RS
Miromatrix Medical, Inc.
General & Plastic Surgery
90d
About Product Code OXH - Regulatory Context
510(k) Submission Activity
5 total 510(k) submissions under product code OXH since 2015, with 5 receiving FDA clearance (average review time: 103 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - OXH Product Code
Recent submissions under OXH have taken an average of 29 days to reach a decision - down from 122 days historically, suggesting improved FDA processing for this classification.
OXH devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →