Cleared Traditional

K240097 - Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (FDA 510(k) Clearance)

K240097 · Ushare Medical, Inc. · General & Plastic Surgery device
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May 2024
Decision
131d
Days
-
Risk

K240097 is an FDA 510(k) clearance for the Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5). Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Ushare Medical, Inc. (Zhuhai, CN). The FDA issued a Cleared decision on May 22, 2024 after a review of 131 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Ushare Medical, Inc. devices

Submission Details

510(k) Number K240097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2024
Decision Date May 22, 2024
Days to Decision 131 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 114d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Consultant

Shenzhen Joyantech Consulting Co., Ltd.
Joyce Yang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 126
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