ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM— 510(k) K111843
Substantially EquivalentSmith & Nephew Inc., Endoscopy Div.
FDA 510(k) clearance K111843 for ACUFEX DIRECTOR APPLICATION ANATOMIC GUIDE SYSTEM, Substantially Equivalent on 2011-11-14. Applicant: Smith & Nephew Inc., Endoscopy Div..
Clearance details
- Applicant
- Smith & Nephew Inc., Endoscopy Div.
- Product code
- Code OLO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Andover, MA, US
Adverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
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.