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Drug-Eluting Sinus Stent

FDA product code OWO · Class 3 · Unknown

9
Registered devices
48
Adverse events
1
Recalls
0
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2022-10-21Intersect ENT, Inc.Sinus Implant product label displays incorrect product information including: "Straight Delivery System", with incorrect reference number and UDI-DI.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.