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FDA 510(k)

Universal Mesh - Sterile

K-Number: K182425 · 2018-11-06

ApplicantStryker Leibinger GmbH & Co KG
Decision Date2018-11-06
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Universal Mesh - Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2018-11-06 under 510(k) number K182425. 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 Universal Mesh - Sterile?

Universal Mesh - Sterile is a medical device that received FDA 510(k) clearance on 2018-11-06. The listed applicant is Stryker Leibinger GmbH & Co KG. The 510(k) number is K182425.

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

Universal Mesh - Sterile received FDA 510(k) clearance on 2018-11-06, under 510(k) number K182425.

Who is the listed applicant for Universal Mesh - Sterile?

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

What is the FDA product code for Universal Mesh - Sterile?

The FDA product code for Universal Mesh - Sterile 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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