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510(k) K172179

Chitogel Endoscopic Sinus Surgery Kit by Chitogel, Ltd. — Product Code LYA

K172179 is an FDA 510(k) premarket notification submitted by Chitogel, Ltd. for the device "Chitogel Endoscopic Sinus Surgery Kit". The FDA issued a decision of Substantially Equivalent on October 17, 2017. 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
October 17, 2017
Date Received
July 19, 2017
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

Other clearances for product code LYA

  • K243655 — TurbAlign (July 11, 2025)
  • K230142 — Epi-Stop Nasal Gel/epistaxis pack (March 22, 2023)
  • K213153 — SPIWay Endonasal Access Guide (October 27, 2021)
  • 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)
  • K153686 — SPIWay Endonasal Access Guide (January 28, 2016)
  • K141816 — HEMOPORE (October 23, 2014)
  • K141704 — NOVASHIELD INJECTABLE NASAL PACKING AND STENT (October 6, 2014)

FDA data resources