Cleared Traditional

Hemoblock_S (Prescription); Hemoblock_S (OTC)

K232216 · Incore Co., Ltd. · General & Plastic Surgery
Apr 2024
Decision
268d
Days
—
Risk

About This 510(k) Submission

K232216 is an FDA 510(k) clearance for the Hemoblock_S (Prescription); Hemoblock_S (OTC), a Hemostatic Wound Dressing Without Thrombin Or Other Biologics, submitted by Incore Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on April 19, 2024, 268 days after receiving the submission on July 26, 2023. This device falls under the General & Plastic Surgery review panel.

Submission Details

510(k) Number K232216 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2023
Decision Date April 19, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

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

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