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FDA 510(k)

RESPONDER Polysaccharide Hemostat

K-Number: K220525 · 2023-12-04

ApplicantStarch Medical, Inc.
Decision Date2023-12-04
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 2023-12-04 under approval number K220525. 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 2023-12-04. It is manufactured by Starch Medical, Inc.. The 510(k) number is K220525.

When was RESPONDER Polysaccharide Hemostat approved by the FDA?

RESPONDER Polysaccharide Hemostat received FDA 510(k) clearance on 2023-12-04, under approval number K220525.

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.

K240454RESPONDER® 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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