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510(k) K120958

POSISEP AND POSISEP X HEMOSTAT DRESSINGS by Hemostasis, LLC — Product Code QSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2012
Date Received
March 30, 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 Hemostasis, LLC

  • K234131 — Resolv Endoscopic Hemostat System (July 26, 2024)
  • K220326 — PosiSep X BAM Hemostat Dressing/Intranasal Splint (November 14, 2022)
  • K210411 — PosiSep EAR Fragmentable Ear Dressing (May 5, 2022)
  • K142348 — OsteoSeal Bone Hemostat (January 23, 2015)
  • K122494 — POSISEP AND POSISEP X HEMOSTAT DRESSING/INTRANASAL SPLINT (March 27, 2013)
  • K122886 — NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING (November 15, 2012)
  • K102459 — NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE (December 3, 2010)
  • K072900 — EXCELARREST FOAM (October 26, 2007)
  • K070211 — TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM (April 5, 2007)

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)