AMADEUS II EPIKERATOME— 510(k) K043150

Name: FDA 510(k) clearance K043150
Creator: U.S. Food and Drug Administration
Published: 2005-01-31

Substantially Equivalent

Sis Ltd., Surgical Instrument Systems

FDA 510(k) clearance K043150 for AMADEUS II EPIKERATOME, Substantially Equivalent on 2005-01-31. Applicant: Sis Ltd., Surgical Instrument Systems. Device class: 1.

Clearance details

Applicant: Sis Ltd., Surgical Instrument Systems
Product code: Code HNO
Device class: Class 1
Regulation: 21 CFR 886.4370
Advisory panel: Ophthalmic
Date received: 2004-11-15
Decision date: 2005-01-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Littleton, CO, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HNO

product code HNO

Injury: 390
Total: 390

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.