One-Fil Putty
K-Number: K243353 · 2025-03-14
ApplicantMediclus Co., Ltd.
Decision Date2025-03-14
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
One-Fil Putty is a medical device manufactured by Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2025-03-14 under approval number K243353. 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?
One-Fil Putty is a medical device that received FDA 510(k) clearance on 2025-03-14. It is manufactured by Mediclus Co., Ltd.. The 510(k) number is K243353.
When was One-Fil Putty approved by the FDA?
One-Fil Putty received FDA 510(k) clearance on 2025-03-14, under approval number K243353.
What company makes One-Fil Putty?
One-Fil Putty is manufactured by Mediclus Co., Ltd..
What is the FDA product code for One-Fil Putty?
The FDA product code for One-Fil Putty 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.