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510(k) K120782

INTERVENTIONAL HEMOSTATIC BANDAGE by Z-Medica Corporation — Product Code QSY

K120782 is an FDA 510(k) premarket notification submitted by Z-Medica Corporation for the device "INTERVENTIONAL HEMOSTATIC BANDAGE". The FDA issued a decision of Substantially Equivalent on March 20, 2013. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Z-Medica Corporation has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 2013
Date Received
March 15, 2012
Clearance Type
Traditional
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

  • 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)
  • K050769 — QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2 (April 14, 2005)

Other clearances for product code QSY

  • K253017 — BloodSTOP iX Trauma Matrix (TM-iX-20) (April 30, 2026)
  • 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)

FDA data resources