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FDA 510(k)

One-Fil

K-Number: K232182 · 2024-01-26

ApplicantMediclus Co., Ltd.
Decision Date2024-01-26
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

One-Fil is a medical device manufactured by Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2024-01-26 under approval number K232182. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the One-Fil?

One-Fil is a medical device that received FDA 510(k) clearance on 2024-01-26. It is manufactured by Mediclus Co., Ltd.. The 510(k) number is K232182.

When was One-Fil approved by the FDA?

One-Fil received FDA 510(k) clearance on 2024-01-26, under approval number K232182.

What company makes One-Fil?

One-Fil is manufactured by Mediclus Co., Ltd..

What is the FDA product code for One-Fil?

The FDA product code for One-Fil is KIF.

Other Devices by Mediclus Co., Ltd.

K230465Hi-Bond Universal K241147Any-Com K252465Any-Core K251884One-Fil Putty Injectable K251283Once-Fil Flow K250823Any-Com Flow

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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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