ENTity USB Videoscope System— 510(k) K254133
Substantially EquivalentOptim, LLC
FDA 510(k) clearance K254133 for ENTity USB Videoscope System, Substantially Equivalent on 2026-05-14. Applicant: Optim, LLC. Device class: 2.
Summary
Optim's ENTity USB Videoscope System is filed under EOB, flexible or rigid nasopharyngoscopes.
Class II, 21 CFR 874.4760. Ear, Nose, Throat is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Optim filed from Sturbridge, Massachusetts. Review took 143 calendar days (December 22, 2025 to May 14, 2026).
Clearance details
- Applicant
- Optim, LLC
- Product code
- Product code EOB
- Device class
- Class 2
- Regulation
- 21 CFR 874.4760
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sturbridge, MA, US
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More clearances from Optim, LLC
view allAdverse events under product code EOB
product code EOB- Malfunction
- 6,143
- Total
- 6,143
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.