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FDA 510(k)

Consolidated Operating Room Equipment (CORE) 2 Console

K-Number: K243958 · 2025-03-21

ApplicantStryker Instruments
Decision Date2025-03-21
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Consolidated Operating Room Equipment (CORE) 2 Console is a medical device manufactured by Stryker Instruments. It received FDA 510(k) clearance on 2025-03-21 under approval number K243958. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Consolidated Operating Room Equipment (CORE) 2 Console?

Consolidated Operating Room Equipment (CORE) 2 Console is a medical device that received FDA 510(k) clearance on 2025-03-21. It is manufactured by Stryker Instruments. The 510(k) number is K243958.

When was Consolidated Operating Room Equipment (CORE) 2 Console approved by the FDA?

Consolidated Operating Room Equipment (CORE) 2 Console received FDA 510(k) clearance on 2025-03-21, under approval number K243958.

What company makes Consolidated Operating Room Equipment (CORE) 2 Console?

Consolidated Operating Room Equipment (CORE) 2 Console is manufactured by Stryker Instruments.

What is the FDA product code for Consolidated Operating Room Equipment (CORE) 2 Console?

The FDA product code for Consolidated Operating Room Equipment (CORE) 2 Console is OLO.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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