CLEAR GUIDE ONE— 510(k) K141806

Substantially Equivalent

Clear Guide Medical

FDA 510(k) clearance K141806 for CLEAR GUIDE ONE, Substantially Equivalent on 2014-09-19. Applicant: Clear Guide Medical.

Clearance details

Applicant: Clear Guide Medical
Product code: Code IYO
Advisory panel: Radiology
Date received: 2014-07-03
Decision date: 2014-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Baltimore, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.