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FDA 510(k)

Any-Etch

K-Number: K260485 · 2026-05-14

ApplicantMediclus Co., Ltd.
Decision Date2026-05-14
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Any-Etch is a medical device manufactured by Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2026-05-14 under approval number K260485. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Any-Etch?

Any-Etch is a medical device that received FDA 510(k) clearance on 2026-05-14. It is manufactured by Mediclus Co., Ltd.. The 510(k) number is K260485.

When was Any-Etch approved by the FDA?

Any-Etch received FDA 510(k) clearance on 2026-05-14, under approval number K260485.

What company makes Any-Etch?

Any-Etch is manufactured by Mediclus Co., Ltd..

What is the FDA product code for Any-Etch?

The FDA product code for Any-Etch is KLE.

Other Devices by Mediclus Co., Ltd.

K260819Any-Com Seal

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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