K254133
- 510(k) number
- K254133
- Device name
- ENTity USB Videoscope System
- Applicant
- Optim, LLC MA · US
- Product code
- EOB — Nasopharyngoscope (Flexible Or Rigid)
- Decision date
- 2026-05-14
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254133.pdf
Official FDA record: K254133
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.