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FDA 510(k)

Stryker Universal Mesh

K-Number: K161821 · 2016-12-08

ApplicantStryker
Decision Date2016-12-08
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Stryker Universal Mesh is a medical device manufactured by Stryker. It received FDA 510(k) clearance on 2016-12-08 under approval number K161821. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stryker Universal Mesh?

Stryker Universal Mesh is a medical device that received FDA 510(k) clearance on 2016-12-08. It is manufactured by Stryker. The 510(k) number is K161821.

When was Stryker Universal Mesh approved by the FDA?

Stryker Universal Mesh received FDA 510(k) clearance on 2016-12-08, under approval number K161821.

What company makes Stryker Universal Mesh?

Stryker Universal Mesh is manufactured by Stryker.

What is the FDA product code for Stryker Universal Mesh?

The FDA product code for Stryker Universal Mesh is GWO.

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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.