STRYKER ESSX MICRODEBRIDER SYSTEM— 510(k) K073633

Name: FDA 510(k) clearance K073633
Creator: U.S. Food and Drug Administration
Published: 2008-08-26

Substantially Equivalent

Stryker 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. Device class: 2.

Clearance details

Applicant: Stryker Ireland Ltd., Instruments Division
Product code: Code ERL
Device class: Class 2
Regulation: 21 CFR 874.4250
Advisory panel: Ear, Nose, Throat
Date received: 2007-12-26
Decision date: 2008-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrigtwohill, Co.Cork, IE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code ERL

product code ERL

Malfunction: 11,234
Total: 11,234

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.