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

Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

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

OXJ is the FDA product code for Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects, 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 abdominal wall defects". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OXJ
Device name
Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects
FDA definition
For reinforcement of soft tissue where weakness exists in abdominal wall defects.
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
2
Ingested recalls
0

Clearances, product code OXJ

By decision year
2 clearances under product code OXJ with a decision year between 2014 and 2016, 2014 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OXJ by decision year
YearClearances
20141
20161

Applicants with the most clearances

Product code OXJ
Applicants holding the most 510(k) clearances under product code OXJ
ApplicantClearances
Molnlycke Health Care1
Molnlycke Health Care, US LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order