FDA 510(k)

EvoEndo Single-Use Endoscopy System

K-Number: K213606 · 2022-02-14

Decision Date2022-02-14

Product CodeFDS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EvoEndo Single-Use Endoscopy System is a medical device manufactured by EvoEndo, Inc.. It received FDA 510(k) clearance on 2022-02-14 under approval number K213606. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EvoEndo Single-Use Endoscopy System?

EvoEndo Single-Use Endoscopy System is a medical device that received FDA 510(k) clearance on 2022-02-14. It is manufactured by EvoEndo, Inc.. The 510(k) number is K213606.

When was EvoEndo Single-Use Endoscopy System approved by the FDA?

EvoEndo Single-Use Endoscopy System received FDA 510(k) clearance on 2022-02-14, under approval number K213606.

What company makes EvoEndo Single-Use Endoscopy System?

EvoEndo Single-Use Endoscopy System is manufactured by EvoEndo, Inc..

What is the FDA product code for EvoEndo Single-Use Endoscopy System?

The FDA product code for EvoEndo Single-Use Endoscopy System is FDS.

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Other Devices by EvoEndo, Inc.

K251708EvoEndo Single-Use Endoscopy System K250900EvoEndo Single-Use Endoscopy System K260573EvoEndo Single-Use Endoscopy System

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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.