FDA 510(k)

ES-Series

K-Number: K260589 · 2026-04-29

Decision Date2026-04-29

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ES-Series is a medical device manufactured by E-Scopics. It received FDA 510(k) clearance on 2026-04-29 under approval number K260589. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ES-Series?

ES-Series is a medical device that received FDA 510(k) clearance on 2026-04-29. It is manufactured by E-Scopics. The 510(k) number is K260589.

When was ES-Series approved by the FDA?

ES-Series received FDA 510(k) clearance on 2026-04-29, under approval number K260589.

What company makes ES-Series?

ES-Series is manufactured by E-Scopics.

What is the FDA product code for ES-Series?

The FDA product code for ES-Series is IYN.

Related Devices (Code: IYN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.