FDA 510(k)

ES1 System

K-Number: K213102 · 2022-01-11

Decision Date2022-01-11

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ES1 System is the device name listed in this FDA 510(k) record. The listed applicant is E-Scopics. It received FDA 510(k) clearance on 2022-01-11 under 510(k) number K213102. 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 ES1 System?

ES1 System is a medical device that received FDA 510(k) clearance on 2022-01-11. The listed applicant is E-Scopics. The 510(k) number is K213102.

When did ES1 System receive FDA 510(k) clearance?

ES1 System received FDA 510(k) clearance on 2022-01-11, under 510(k) number K213102.

Who is the listed applicant for ES1 System?

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 ES1 System?

The FDA product code for ES1 System 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.

K260748ES-Series K260589ES-Series K232336ES Series V2

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.