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FDA 510(k)

One-Fil Putty

K-Number: K243353 · 2025-03-14

Decision Date2025-03-14
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

One-Fil Putty is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2025-03-14 under 510(k) 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. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K243353.

When did One-Fil Putty receive FDA 510(k) clearance?

One-Fil Putty received FDA 510(k) clearance on 2025-03-14, under 510(k) number K243353.

Who is the listed applicant for One-Fil Putty?

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 Putty?

The FDA product code for One-Fil Putty 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.

View all 15 devices →

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.