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FDA 510(k)

ENTity USB Videoscope System

K-Number: K254133 · 2026-05-14

ApplicantOptim, LLC
Decision Date2026-05-14
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ENTity USB Videoscope System is a medical device manufactured by Optim, LLC. It received FDA 510(k) clearance on 2026-05-14 under approval number K254133. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENTity USB Videoscope System?

ENTity USB Videoscope System is a medical device that received FDA 510(k) clearance on 2026-05-14. It is manufactured by Optim, LLC. The 510(k) number is K254133.

When was ENTity USB Videoscope System approved by the FDA?

ENTity USB Videoscope System received FDA 510(k) clearance on 2026-05-14, under approval number K254133.

What company makes ENTity USB Videoscope System?

ENTity USB Videoscope System is manufactured by Optim, LLC.

What is the FDA product code for ENTity USB Videoscope System?

The FDA product code for ENTity USB Videoscope System is EOB.

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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