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 a medical device manufactured by Stryker Leibinger GmbH & Co KG. It received FDA 510(k) clearance on 2018-11-06 under approval 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. It is manufactured by Stryker Leibinger GmbH & Co KG. The 510(k) number is K182425.
When was Universal Mesh - Sterile approved by the FDA?
Universal Mesh - Sterile received FDA 510(k) clearance on 2018-11-06, under approval number K182425.
What company makes Universal Mesh - Sterile?
Universal Mesh - Sterile is manufactured by Stryker Leibinger GmbH & Co KG.
What is the FDA product code for Universal Mesh - Sterile?
The FDA product code for Universal Mesh - Sterile is GWO.
Other Devices by Stryker Leibinger GmbH & Co KG
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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.