FDA 510(k)

Consolidated Operating Room Equipment (CORE) 2 Console

K-Number: K243958 · 2025-03-21

Decision Date2025-03-21

Product CodeOLO

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Consolidated Operating Room Equipment (CORE) 2 Console is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2025-03-21 under 510(k) 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. The listed applicant is Stryker Instruments. The 510(k) number is K243958.

When did Consolidated Operating Room Equipment (CORE) 2 Console receive FDA 510(k) clearance?

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

Who is the listed applicant for Consolidated Operating Room Equipment (CORE) 2 Console?

The FDA 510(k) record lists Stryker Instruments as the applicant. This does not by itself establish the device manufacturer.

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.