ClearHemograsper
K-Number: K242857 · 2025-05-21
ApplicantFinemedix Co., Ltd.
Decision Date2025-05-21
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
ClearHemograsper is a medical device manufactured by Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2025-05-21 under approval number K242857. The device is classified under product code KGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ClearHemograsper?
ClearHemograsper is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Finemedix Co., Ltd.. The 510(k) number is K242857.
When was ClearHemograsper approved by the FDA?
ClearHemograsper received FDA 510(k) clearance on 2025-05-21, under approval number K242857.
What company makes ClearHemograsper?
ClearHemograsper is manufactured by Finemedix Co., Ltd..
What is the FDA product code for ClearHemograsper?
The FDA product code for ClearHemograsper is KGE.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.