Once-Fil Flow
K-Number: K251283 · 2025-06-06
ApplicantMediclus Co., Ltd.
Decision Date2025-06-06
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Once-Fil Flow is a medical device manufactured by Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2025-06-06 under approval number K251283. 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 Once-Fil Flow?
Once-Fil Flow is a medical device that received FDA 510(k) clearance on 2025-06-06. It is manufactured by Mediclus Co., Ltd.. The 510(k) number is K251283.
When was Once-Fil Flow approved by the FDA?
Once-Fil Flow received FDA 510(k) clearance on 2025-06-06, under approval number K251283.
What company makes Once-Fil Flow?
Once-Fil Flow is manufactured by Mediclus Co., Ltd..
What is the FDA product code for Once-Fil Flow?
The FDA product code for Once-Fil Flow 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.