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510(k) K080247

QUIKCLOT NOSEBLEED by Z-Medica Corporation — Product Code LYA

K080247 is an FDA 510(k) premarket notification submitted by Z-Medica Corporation for the device "QUIKCLOT NOSEBLEED". The FDA issued a decision of Substantially Equivalent on February 27, 2008. The device falls under product code LYA (Splint, Intranasal Septal), a Class I device regulated under 21 CFR 874.4780. Z-Medica Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2008
Date Received
January 31, 2008
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 by Z-Medica Corporation

  • K120782 — INTERVENTIONAL HEMOSTATIC BANDAGE (March 20, 2013)
  • K090620 — QUIKCLOT INTEVENTIONAL, MODEL P/N 182 (April 8, 2009)
  • K072474 — QUIKCLOT EX (October 16, 2007)
  • K070010 — QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER (January 25, 2007)
  • K061767 — QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+ (July 19, 2006)
  • K051955 — QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE (August 10, 2005)
  • K050769 — QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2 (April 14, 2005)

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