STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM— 510(k) K112593

Substantially Equivalent

Stryker Corporation

FDA 510(k) clearance K112593 for STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM, Substantially Equivalent on 2012-05-01. Applicant: Stryker Corporation.

Clearance details

Applicant: Stryker Corporation
Product code: Code ERL
Advisory panel: Ear, Nose, Throat
Date received: 2011-09-07
Decision date: 2012-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

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.