AMADEUS II EPIKERATOME— 510(k) K043150
Substantially EquivalentSis 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.
Clearance details
- Applicant
- Sis Ltd., Surgical Instrument Systems
- Product code
- Code HNO
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Littleton, CO, US
Adverse events under product code HNO
product code HNO- Injury
- 390
- Total
- 390
Source: openFDA MAUDE database, through . 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.