K161514

Substantially Equivalent

Precision Thin Reciprocating Blade, 0.010in.

Applicant: Stryker Corporation
Product code: EQJ
Advisory panel: Ear, Nose, Throat
Date received: 2016-06-02
Decision date: 2017-01-17
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, 2020-01-01 through 2026-04-23. 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.