Cleared Special

RESPONDER? Polysaccharide Hemostat

K240454 · Starch Medical, Inc. · General & Plastic Surgery

Mar 2024

Decision

29d

Days

—

Risk

About This 510(k) Submission

K240454 is an FDA 510(k) clearance for the RESPONDER? Polysaccharide Hemostat, a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Starch Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on March 15, 2024, 29 days after receiving the submission on February 15, 2024. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number	K240454 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 2024
Decision Date	March 15, 2024
Days to Decision	29 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	QSY — Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class	—
Definition	To Temporarily Control Bleeding And Cover External Wounds.