FDA 510(k)

ES Series V2

K-Number: K232336 · 2023-09-26

Decision Date2023-09-26

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ES Series V2 is the device name listed in this FDA 510(k) record. The listed applicant is E-Scopics. It received FDA 510(k) clearance on 2023-09-26 under 510(k) number K232336. 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 V2?

ES Series V2 is a medical device that received FDA 510(k) clearance on 2023-09-26. The listed applicant is E-Scopics. The 510(k) number is K232336.

When did ES Series V2 receive FDA 510(k) clearance?

ES Series V2 received FDA 510(k) clearance on 2023-09-26, under 510(k) number K232336.

Who is the listed applicant for ES Series V2?

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 V2?

The FDA product code for ES Series V2 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.

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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.