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FDA 510(k)

EvoEndo Single-Use Endoscopy System

K-Number: K251708 · 2025-10-10

ApplicantEvoEndo, Inc.
Decision Date2025-10-10
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 2025-10-10 under approval number K251708. 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 2025-10-10. It is manufactured by EvoEndo, Inc.. The 510(k) number is K251708.

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

EvoEndo Single-Use Endoscopy System received FDA 510(k) clearance on 2025-10-10, under approval number K251708.

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.

K213606EvoEndo Single-Use Endoscopy System K250900EvoEndo Single-Use Endoscopy System K260573EvoEndo Single-Use Endoscopy System

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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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