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510(k) K232216

Hemoblock_S (Prescription); Hemoblock_S (OTC) by Incore Co., Ltd. — Product Code QSY

K232216 is an FDA 510(k) premarket notification submitted by Incore Co., Ltd. for the device "Hemoblock_S (Prescription); Hemoblock_S (OTC)". The FDA issued a decision of Substantially Equivalent on April 19, 2024. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Incore Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2024
Date Received
July 26, 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 Incore Co., Ltd.

  • K221054 — CORE-INJECTOR (December 21, 2022)
  • K220846 — CORE-SNARE (November 21, 2022)
  • K220081 — CORE-SPORT (September 28, 2022)
  • K213338 — CORE-CLIP (June 23, 2022)
  • K211148 — CORE-Trocar (June 21, 2022)

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)
  • 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)

FDA data resources