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

Mesh, Surgical, Collagen, Diaphragmatic Hernia

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

OWV is the FDA product code for Mesh, Surgical, Collagen, Diaphragmatic Hernia, 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 diaphragmatic hernia repair". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
OWV
Device name
Mesh, Surgical, Collagen, Diaphragmatic Hernia
FDA definition
For reinforcement of soft tissue where weakness exists during diaphragmatic hernia repair.
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
1

Clearances, product code OWV

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

Applicants with the most clearances

Product code OWV
Applicants holding the most 510(k) clearances under product code OWV
ApplicantClearances
Cook Biotech, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code