510(k) K254133— ENTity USB Videoscope System

Substantially Equivalent

Optim, LLC

Clearance details

Applicant: Optim, LLC
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 2025-12-22
Decision date: 2026-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturbridge, MA, US

Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.