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510(k) K240454

RESPONDER® Polysaccharide Hemostat by Starch Medical, Inc. — Product Code QSY

K240454 is an FDA 510(k) premarket notification submitted by Starch Medical, Inc. for the device "RESPONDER® Polysaccharide Hemostat". The FDA issued a decision of Substantially Equivalent on March 15, 2024. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Starch Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2024
Date Received
February 15, 2024
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 Starch Medical, Inc.

  • K220525 — RESPONDER Polysaccharide Hemostat (December 4, 2023)

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)
  • 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