XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM— 510(k) K082871
Substantially EquivalentSis Ltd., Surgical Instrument Systems
FDA 510(k) clearance K082871 for XACT LENS INSERTER SYSTEM, MODELS 6MM, 7MM, Substantially Equivalent on 2009-07-09. Applicant: Sis Ltd., Surgical Instrument Systems.
Clearance details
- Applicant
- Sis Ltd., Surgical Instrument Systems
- Product code
- Code MSS
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Greenwood Village, CO, US
Adverse events under product code MSS
product code MSS- Injury
- 385
- Malfunction
- 2,033
- Total
- 2,418
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.