FDA 510(k)

ES-Series

K-Number: K260748 · 2026-06-09

Decision Date2026-06-09

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ES-Series is the device name listed in this FDA 510(k) record. The listed applicant is E-Scopics. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K260748. 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 2026-06-09. The listed applicant is E-Scopics. The 510(k) number is K260748.

When did ES-Series receive FDA 510(k) clearance?

ES-Series received FDA 510(k) clearance on 2026-06-09, under 510(k) number K260748.

Who is the listed applicant for ES-Series?

The FDA 510(k) record lists E-Scopics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ES-Series?

The FDA product code for ES-Series is IYN.

Other records listing E-Scopics 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.

K260589ES-Series K232336ES Series V2 K213102ES1 System

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.