Hemoblock_S (Prescription); Hemoblock_S (OTC)— 510(k) K232216

Substantially Equivalent

Incore Co., Ltd.

FDA 510(k) clearance K232216 for Hemoblock_S (Prescription); Hemoblock_S (OTC), Substantially Equivalent on 2024-04-19. Applicant: Incore Co., Ltd..

Clearance details

Applicant: Incore Co., Ltd.
Product code: Code QSY
Advisory panel: Unknown
Date received: 2023-07-26
Decision date: 2024-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.