One-Stop
K-Number: K253797 · 2026-02-27
ApplicantMediclus Co., Ltd.
Decision Date2026-02-27
Product CodeMVL
DecisionSubstantially Equivalent
Device Summary
One-Stop is a medical device manufactured by Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2026-02-27 under approval 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. It is manufactured by Mediclus Co., Ltd.. The 510(k) number is K253797.
When was One-Stop approved by the FDA?
One-Stop received FDA 510(k) clearance on 2026-02-27, under approval number K253797.
What company makes One-Stop?
One-Stop is manufactured by Mediclus Co., Ltd..
What is the FDA product code for One-Stop?
The FDA product code for One-Stop is MVL.
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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.