RESPONDER® Polysaccharide Hemostat (K240454) - FDA 510(k) Clearance

K240454 is an FDA 510(k) clearance for the RESPONDER® Polysaccharide Hemostat. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Starch Medical, Inc. (San Jose, US). The FDA issued a Cleared decision on March 15, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Starch Medical, Inc. devices