STRYKER ESSX MICRODEBRIDER SYSTEM— 510(k) K073633
Substantially EquivalentStryker Ireland Ltd., Instruments Division
FDA 510(k) clearance K073633 for STRYKER ESSX MICRODEBRIDER SYSTEM, Substantially Equivalent on 2008-08-26. Applicant: Stryker Ireland Ltd., Instruments Division.
Clearance details
- Applicant
- Stryker Ireland Ltd., Instruments Division
- Product code
- Code ERL
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carrigtwohill, Co.Cork, IE
Adverse events under product code ERL
product code ERL- Malfunction
- 11,234
- Total
- 11,234
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.