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

Mesh, Surgical, Collagen, Fistula

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

OXN is the FDA product code for Mesh, Surgical, Collagen, Fistula, 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 the repair of fistulas". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OXN
Device name
Mesh, Surgical, Collagen, Fistula
FDA definition
For reinforcement of soft tissue where weakness exists during the repair of fistulas.
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
1
Ingested recalls
0

Clearances, product code OXN

By decision year
1 clearance under product code OXN with a decision year between 2019 and 2019, 2019 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OXN by decision year
YearClearances
20191

Applicants with the most clearances

Product code OXN
Applicants holding the most 510(k) clearances under product code OXN
ApplicantClearances
Cook Biotech Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code