Precision Thin Reciprocating Blade, 0.010in.— 510(k) K161514
Substantially EquivalentStryker Corporation
FDA 510(k) clearance K161514 for Precision Thin Reciprocating Blade, 0.010in., Substantially Equivalent on 2017-01-17. Applicant: Stryker Corporation.
Clearance details
- Applicant
- Stryker Corporation
- Product code
- Code EQJ
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalamazoo, MI, US
Adverse events under product code EQJ
product code EQJ- Malfunction
- 1,552
- Total
- 1,552
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.