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510(k) K192671

Hemostatic Xerogel Sponge by Solaplus Biotech Co., Ltd. — Product Code QSY

K192671 is an FDA 510(k) premarket notification submitted by Solaplus Biotech Co., Ltd. for the device "Hemostatic Xerogel Sponge". The FDA issued a decision of Substantially Equivalent on August 28, 2020. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2020
Date Received
September 26, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

To temporarily control bleeding and cover external wounds.

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  • K240454 — RESPONDER® Polysaccharide Hemostat (March 15, 2024)
  • K220525 — RESPONDER Polysaccharide Hemostat (December 4, 2023)
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FDA data resources