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

Drug-Eluting Sinus Stent

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FDA source (opens on fda.gov)

OWO is the FDA product code for Drug-Eluting Sinus Stent, a class III device type. FDA's definition for this code reads: "Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
OWO
Device name
Drug-Eluting Sinus Stent
FDA definition
Mechanically maintain patency following ethmoid sinus surgery. By also eluting drugs, reduce the need for post-operative intervention such as surgical adhesion lysis and/or use of oral steroids.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code