Consolidated Operating Room Equipment (CORE) 2 Console— 510(k) K243958
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K243958 for Consolidated Operating Room Equipment (CORE) 2 Console, Substantially Equivalent on 2025-03-21. Applicant: Stryker Instruments. Device class: 2.
Clearance details
- Applicant
- Stryker Instruments
- Product code
- Product code OLO
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Portage, MI, US
Recent devices under product code OLO
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- K261544 — Hydro Irrigation System
- K253679 — Hydro Irrigation System
Adverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
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.