Decision Date2017-08-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Stryker Integrated Bipolar Cord and Tubing Sets is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Instruments. It received FDA 510(k) clearance on 2017-08-22 under 510(k) number K172367. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Stryker Integrated Bipolar Cord and Tubing Sets?
Stryker Integrated Bipolar Cord and Tubing Sets is a medical device that received FDA 510(k) clearance on 2017-08-22. The listed applicant is Stryker Instruments. The 510(k) number is K172367.
When did Stryker Integrated Bipolar Cord and Tubing Sets receive FDA 510(k) clearance?
Stryker Integrated Bipolar Cord and Tubing Sets received FDA 510(k) clearance on 2017-08-22, under 510(k) number K172367.
Who is the listed applicant for Stryker Integrated Bipolar Cord and Tubing Sets?
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 Stryker Integrated Bipolar Cord and Tubing Sets?
The FDA product code for Stryker Integrated Bipolar Cord and Tubing Sets is GEI.
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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.