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FDA 510(k)

One-Fil LC

K-Number: K261728 · 2026-07-21

ApplicantMediclus Co., Ltd.
Decision Date2026-07-21
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

One-Fil LC is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2026-07-21 under 510(k) number K261728. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the One-Fil LC?

One-Fil LC is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K261728.

When did One-Fil LC receive FDA 510(k) clearance?

One-Fil LC received FDA 510(k) clearance on 2026-07-21, under 510(k) number K261728.

Who is the listed applicant for One-Fil LC?

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

What is the FDA product code for One-Fil LC?

The FDA product code for One-Fil LC is EJK.

Other records listing Mediclus Co., Ltd. as applicant

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Related Devices (Code: EJK)

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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.

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