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FDA 510(k)

ES1 System

K-Number: K213102 · 2022-01-11

ApplicantE-Scopics
Decision Date2022-01-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ES1 System is a medical device manufactured by E-Scopics. It received FDA 510(k) clearance on 2022-01-11 under approval 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. It is manufactured by E-Scopics. The 510(k) number is K213102.

When was ES1 System approved by the FDA?

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

What company makes ES1 System?

ES1 System is manufactured by E-Scopics.

What is the FDA product code for ES1 System?

The FDA product code for ES1 System is IYN.

Other Devices by E-Scopics

K232336ES Series V2 K260589ES-Series

Related Devices (Code: IYN)

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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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