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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 the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2016-12-08 under 510(k) 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. The listed applicant is Stryker. The 510(k) number is K161821.

When did Stryker Universal Mesh receive FDA 510(k) clearance?

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

Who is the listed applicant for Stryker Universal Mesh?

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

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

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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