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FDA 510(k)

One-Stop

K-Number: K253797 · 2026-02-27

Decision Date2026-02-27
Product CodeMVL
DecisionSubstantially Equivalent

Device Summary

One-Stop 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 2026-02-27 under 510(k) number K253797. The device is classified under product code MVL. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the One-Stop?

One-Stop is a medical device that received FDA 510(k) clearance on 2026-02-27. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K253797.

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

One-Stop received FDA 510(k) clearance on 2026-02-27, under 510(k) number K253797.

Who is the listed applicant for One-Stop?

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-Stop?

The FDA product code for One-Stop is MVL.

Other records listing Mediclus Co., Ltd. as applicant

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.

View all 15 devices →

Related Devices (Code: MVL)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.