One-Fil Putty Injectable
K-Number: K251884 · 2025-08-22
ApplicantMediclus Co., Ltd.
Decision Date2025-08-22
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
One-Fil Putty Injectable is a medical device manufactured by Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2025-08-22 under approval number K251884. 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 Putty Injectable?
One-Fil Putty Injectable is a medical device that received FDA 510(k) clearance on 2025-08-22. It is manufactured by Mediclus Co., Ltd.. The 510(k) number is K251884.
When was One-Fil Putty Injectable approved by the FDA?
One-Fil Putty Injectable received FDA 510(k) clearance on 2025-08-22, under approval number K251884.
What company makes One-Fil Putty Injectable?
One-Fil Putty Injectable is manufactured by Mediclus Co., Ltd..
What is the FDA product code for One-Fil Putty Injectable?
The FDA product code for One-Fil Putty Injectable is KIF.
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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.