AmplifEYE— 510(k) K160846

Name: FDA 510(k) clearance K160846
Creator: U.S. Food and Drug Administration
Published: 2016-07-14

Substantially Equivalent

Medivators, Inc.

FDA 510(k) clearance K160846 for AmplifEYE, Substantially Equivalent on 2016-07-14. Applicant: Medivators, Inc.. Device class: 2.

Clearance details

Applicant: Medivators, Inc.
Product code: Code FED
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2016-03-28
Decision date: 2016-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Conroe, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FED

product code FED

Death: 10
Total: 10

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.