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510(k) K013390

QUICKCLOT by On Site Gas Systems, Inc. — Product Code QSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 2002
Date Received
October 15, 2001
Clearance Type
Traditional
Expedited Review
Yes
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 On Site Gas Systems, Inc.

  • K092636 — POGS, MODEL 65/130 (January 7, 2010)
  • K063454 — POGS, MODEL 33C (May 9, 2007)
  • K041664 — PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C (July 29, 2004)
  • K030920 — POGS 33 (March 10, 2004)
  • K021581 — HEMOSORB (July 12, 2002)
  • K021082 — ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATION SYSTEM-1.0 AND 5.0 (May 22, 2002)
  • K020362 — P.O.G.S. 3.3 PORTABLE OXYGEN GENERATOR SYSTEM (February 12, 2002)
  • K014078 — ON SITE GAS SYSTEMS PORTABLE OXYGEN GENERATOR SYSTEM (January 8, 2002)

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)