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510(k) K230589

Celox Rapid X-Ray Gauze by Medtrade Products , Ltd. — Product Code QSY

K230589 is an FDA 510(k) premarket notification submitted by Medtrade Products , Ltd. for the device "Celox Rapid X-Ray Gauze". The FDA issued a decision of Substantially Equivalent on November 17, 2023. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Medtrade Products , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2023
Date Received
March 2, 2023
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 Medtrade Products , Ltd.

  • K161274 — Bondiloxs Topical Hemostatic Granules (January 18, 2017)
  • K132333 — BONDILOXS TOPICAL HEMOSTATIC DRESSING (June 25, 2014)
  • K120930 — CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM (October 26, 2012)
  • K113560 — CELOX GAUZE PRO (August 1, 2012)
  • K110386 — CELOX RAPID GAUZE (May 10, 2011)
  • K102965 — CELOX TRAUMA GAUZE AG, CELOX HEMOSTATIC ANTIBACTERIAL TRAUMA GAUZE, OMNI-STAT TR (December 8, 2010)
  • K093519 — MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET (January 14, 2010)
  • K090780 — MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE (November 20, 2009)
  • K091795 — MEDTRADE PRODUCTS CELOX TRAUMA GAUZE (November 20, 2009)
  • K080097 — MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET (July 9, 2008)

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)
  • K213413 — Hemostatic Dressing (September 1, 2023)

FDA data resources