K240454 - RESPONDER® Polysaccharide Hemostat (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.

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