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

Mesh, Surgical, Collagen, Staple Line Reinforcement

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

OXE is the FDA product code for Mesh, Surgical, Collagen, Staple Line Reinforcement, 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 during staple line reinforcement procedures". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OXE
Device name
Mesh, Surgical, Collagen, Staple Line Reinforcement
FDA definition
For reinforcement of soft tissue where weakness exists during staple line reinforcement procedures.
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
4
Ingested recalls
0

Clearances, product code OXE

By decision year
4 clearances under product code OXE with a decision year between 2002 and 2017, 2002 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OXE by decision year
YearClearances
20021
20031
20161
20171

Applicants with the most clearances

Product code OXE
Applicants holding the most 510(k) clearances under product code OXE
ApplicantClearances
Cook Biotech Incorporated1
Cook Biotech, Inc.1
Kerecis Limited1
SYNOVIS LIFE TECHNOLOGIES, Inc. (A Subsidiary of Baxter International Inc.)1

Companies listing this code with FDA

Companies whose registered establishments list this code