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

Mesh, Surgical, Collagen, Large Abdominal Wall Defects

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

OXK is the FDA product code for Mesh, Surgical, Collagen, 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
OXK
Device name
Mesh, Surgical, Collagen, 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 OXK

By decision year
2 clearances under product code OXK with a decision year between 2012 and 2013, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OXK by decision year
YearClearances
20121
20131

Applicants with the most clearances

Product code OXK
Applicants holding the most 510(k) clearances under product code OXK
ApplicantClearances
LifeCell Corp2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order