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FDA 510(k)

Stryker Consolidated Operating Room Equipment (CORE) 2 Console

K-Number: K171840 · 2017-09-15

Decision Date2017-09-15
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Stryker Consolidated Operating Room Equipment (CORE) 2 Console is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K171840. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Stryker Consolidated Operating Room Equipment (CORE) 2 Console is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Stryker Corporation. The 510(k) number is K171840.

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

Stryker Consolidated Operating Room Equipment (CORE) 2 Console received FDA 510(k) clearance on 2017-09-15, under 510(k) number K171840.

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

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

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Stryker Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: ERL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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