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510(k) K122886

NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING by Hemostasis, LLC — Product Code QSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 15, 2012
Date Received
September 20, 2012
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 Hemostasis, LLC

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  • 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)
  • K120958 — POSISEP AND POSISEP X HEMOSTAT DRESSINGS (July 25, 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)