510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OXHClass II

Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

OXH is the FDA product code for Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery". As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OXH
Device name
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
FDA definition
For reinforcement of soft tissue where weakness exists in plastic and reconstructive surgery.
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code OXH

By decision year
5 clearances under product code OXH with a decision year between 2015 and 2025, 2015 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OXH by decision year
YearClearances
20151
20161
20171
20211
20251

Applicants with the most clearances

Product code OXH
Applicants holding the most 510(k) clearances under product code OXH
ApplicantClearances
Kerecis Limited2
Miromatrix Medical, Inc.2
Integra Lifesciences Corporation (Owner of Tei Biosciences)1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 23 companies shown, in name order