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510(k) K092401

SINEXUS SINUS STENT GEN 2, MODEL 1999-25 by Sinexus, Inc. — Product Code LYA

K092401 is an FDA 510(k) premarket notification submitted by Sinexus, Inc. for the device "SINEXUS SINUS STENT GEN 2, MODEL 1999-25". The FDA issued a decision of Substantially Equivalent on November 17, 2009. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2009
Date Received
August 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Splint, Intranasal Septal
Device Class
Class I
Regulation Number
874.4780
Review Panel
EN
Submission Type

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  • K202623 — Novapak Nasal Sinus Packing and Stent (December 8, 2020)
  • K181696 — ChitoZolve (November 30, 2018)
  • K180141 — SPIWay Endonasal Access Guide (February 16, 2018)
  • K170913 — Composite Removable Sinus Stent System (December 15, 2017)
  • K172179 — Chitogel Endoscopic Sinus Surgery Kit (October 17, 2017)
  • K153686 — SPIWay Endonasal Access Guide (January 28, 2016)
  • K141816 — HEMOPORE (October 23, 2014)

FDA data resources