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FDA 510(k)

RESPONDER® Polysaccharide Hemostat

K-Number: K240454 · 2024-03-15

ApplicantStarch Medical, Inc.
Decision Date2024-03-15
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

RESPONDER® Polysaccharide Hemostat is a medical device manufactured by Starch Medical, Inc.. It received FDA 510(k) clearance on 2024-03-15 under approval number K240454. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESPONDER® Polysaccharide Hemostat?

RESPONDER® Polysaccharide Hemostat is a medical device that received FDA 510(k) clearance on 2024-03-15. It is manufactured by Starch Medical, Inc.. The 510(k) number is K240454.

When was RESPONDER® Polysaccharide Hemostat approved by the FDA?

RESPONDER® Polysaccharide Hemostat received FDA 510(k) clearance on 2024-03-15, under approval number K240454.

What company makes RESPONDER® Polysaccharide Hemostat?

RESPONDER® Polysaccharide Hemostat is manufactured by Starch Medical, Inc..

What is the FDA product code for RESPONDER® Polysaccharide Hemostat?

The FDA product code for RESPONDER® Polysaccharide Hemostat is QSY.

Other Devices by Starch Medical, Inc.

K220525RESPONDER Polysaccharide Hemostat

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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