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510(k) K102944

CORELEADER HEMO-PAD MODEL CPII 02030 by Coreleader Biotech Co., Ltd. — Product Code QSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2011
Date Received
October 4, 2010
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 Coreleader Biotech Co., Ltd.

  • K151204 — HEMO-Bandage (July 31, 2015)
  • K141382 — BIOS KING BIOCELLULOSE FILM (February 10, 2015)
  • K123394 — CORELEADER HYDRO-HEALER HYDROCOLLOID WOUND DRESSING (June 6, 2013)
  • K111578 — CORELEADER COLLA-ALGI FIBER MODEL CAW (September 23, 2011)
  • K111733 — CORELEADER SCAR-DIMMER (September 22, 2011)
  • K102942 — CORELEADER ALGIPLASTER MODEL AP 050501 (June 22, 2011)
  • K102946 — CORELEADER COLLA-PAD MODEL CS 03030 (May 20, 2011)
  • K102943 — CORELEADER ALGI-FIBER WOUND DRESSING MODEL ADW 05050 (April 12, 2011)

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)