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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 the device name listed in this FDA 510(k) record. The listed applicant is Optim, LLC. It received FDA 510(k) clearance on 2026-05-14 under 510(k) 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. The listed applicant is Optim, LLC. The 510(k) number is K254133.

When did ENTity USB Videoscope System receive FDA 510(k) clearance?

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

Who is the listed applicant for ENTity USB Videoscope System?

The FDA 510(k) record lists Optim, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Optim, LLC 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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Related Devices (Code: EOB)

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.

K261544Hydro Irrigation SystemStryker InstrumentsK253184Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B)Zhuhai Wesee Meditech Co., Ltd.K252050Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DOlympus Medical Systems CorporationK241731Outlook Surgical Versa One System (8900139)Resnent, LLCK243639Portare System (FA-001)Grumpy Innovation, Inc.K243380VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500)Olympus Medical Systems Corporation

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.

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