Home / 510(k) Clearances / K113585

510(k) K113585

NASAL/EPISTAXIS PACK by Cogent Therapeutics, LLC — Product Code LYA

K113585 is an FDA 510(k) premarket notification submitted by Cogent Therapeutics, LLC for the device "NASAL/EPISTAXIS PACK". The FDA issued a decision of Substantially Equivalent on April 25, 2012. 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
April 25, 2012
Date Received
December 5, 2011
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)
  • 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