ClearHemograsper— 510(k) K242857

Substantially Equivalent

Finemedix Co., Ltd.

FDA 510(k) clearance K242857 for ClearHemograsper, Substantially Equivalent on 2025-05-21. Applicant: Finemedix Co., Ltd..

Clearance details

Applicant: Finemedix Co., Ltd.
Product code: Code KGE
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-20
Decision date: 2025-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daegu, KR

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