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FDA 510(k)

ClearHemograsper

K-Number: K242857 · 2025-05-21

ApplicantFinemedix Co., Ltd.
Decision Date2025-05-21
Product CodeKGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ClearHemograsper is the device name listed in this FDA 510(k) record. The listed applicant is Finemedix Co., Ltd.. It received FDA 510(k) clearance on 2025-05-21 under 510(k) 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. The listed applicant is Finemedix Co., Ltd.. The 510(k) number is K242857.

When did ClearHemograsper receive FDA 510(k) clearance?

ClearHemograsper received FDA 510(k) clearance on 2025-05-21, under 510(k) number K242857.

Who is the listed applicant for ClearHemograsper?

The FDA 510(k) record lists Finemedix Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearHemograsper?

The FDA product code for ClearHemograsper is KGE.

Other records listing Finemedix Co., Ltd. as applicant

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Related Devices (Code: KGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251807Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LROlympus Medical Systems Corp.K250187Disposable Hot Biopsy Forceps (FD-210U); Disposable Hot Biopsy Forceps (FD-230U)Olympus Medical Systems CorporationK231721Disposable Hot Biopsy ForcepsBeijing Zksk Technology Co., Ltd.K220053Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm CorporationK210406Bipolar Coagulation ForecepsHangzhou AGS MedTech Co., Ltd.K202438Ensure Single-Use Coagulation ForcepsMicro-Tech (Nanjing) Co., Ltd.

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.

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