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FDA 510(k)

Hemostatic Xerogel Sponge

K-Number: K192671 · 2020-08-28

ApplicantSolaplus Biotech Co., Ltd.
Decision Date2020-08-28
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

Hemostatic Xerogel Sponge is a medical device manufactured by Solaplus Biotech Co., Ltd.. It received FDA 510(k) clearance on 2020-08-28 under approval number K192671. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hemostatic Xerogel Sponge?

Hemostatic Xerogel Sponge is a medical device that received FDA 510(k) clearance on 2020-08-28. It is manufactured by Solaplus Biotech Co., Ltd.. The 510(k) number is K192671.

When was Hemostatic Xerogel Sponge approved by the FDA?

Hemostatic Xerogel Sponge received FDA 510(k) clearance on 2020-08-28, under approval number K192671.

What company makes Hemostatic Xerogel Sponge?

Hemostatic Xerogel Sponge is manufactured by Solaplus Biotech Co., Ltd..

What is the FDA product code for Hemostatic Xerogel Sponge?

The FDA product code for Hemostatic Xerogel Sponge is QSY.

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Official Source

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

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