One-Fil
K-Number: K232182 · 2024-01-26
Device Summary
Frequently Asked Questions
What is the One-Fil?
One-Fil is a medical device that received FDA 510(k) clearance on 2024-01-26. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K232182.
When did One-Fil receive FDA 510(k) clearance?
One-Fil received FDA 510(k) clearance on 2024-01-26, under 510(k) number K232182.
Who is the listed applicant for One-Fil?
The FDA 510(k) record lists Mediclus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for One-Fil?
The FDA product code for One-Fil is KIF.
Other records listing Mediclus Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: KIF)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.