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510(k) K050769

QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172 by Z-Medica Corporation — Product Code QSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2005
Date Received
March 25, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

To temporarily control bleeding and cover external wounds.

Other clearances by Z-Medica Corporation

  • K120782 — INTERVENTIONAL HEMOSTATIC BANDAGE (March 20, 2013)
  • K090620 — QUIKCLOT INTEVENTIONAL, MODEL P/N 182 (April 8, 2009)
  • K080247 — QUIKCLOT NOSEBLEED (February 27, 2008)
  • 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)

Other clearances for product code QSY

  • K251700 — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x (February 26, 2026)
  • K250319 — MFUSE (MS001) (December 15, 2025)
  • K253609 — TRAUMAGEL® 2.0 Hemostatic Gel (December 12, 2025)
  • K240713 — TRAUMAGEL® (August 14, 2024)
  • K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (May 22, 2024)
  • K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) (April 19, 2024)
  • K240454 — RESPONDER® Polysaccharide Hemostat (March 15, 2024)
  • K220525 — RESPONDER Polysaccharide Hemostat (December 4, 2023)
  • K230589 — Celox Rapid X-Ray Gauze (November 17, 2023)
  • K213413 — Hemostatic Dressing (September 1, 2023)