EsFlow PLUS
K-Number: K250317 · 2025-05-30
ApplicantSpident Co., Ltd.
Decision Date2025-05-30
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
EsFlow PLUS is a medical device manufactured by Spident Co., Ltd.. It received FDA 510(k) clearance on 2025-05-30 under approval number K250317. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EsFlow PLUS?
EsFlow PLUS is a medical device that received FDA 510(k) clearance on 2025-05-30. It is manufactured by Spident Co., Ltd.. The 510(k) number is K250317.
When was EsFlow PLUS approved by the FDA?
EsFlow PLUS received FDA 510(k) clearance on 2025-05-30, under approval number K250317.
What company makes EsFlow PLUS?
EsFlow PLUS is manufactured by Spident Co., Ltd..
What is the FDA product code for EsFlow PLUS?
The FDA product code for EsFlow PLUS is EBF.
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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.