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FDA 510(k)

LaparoGuard

K-Number: K182434 · 2018-12-13

ApplicantMariner Endosurgery, Inc.
Decision Date2018-12-13
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LaparoGuard is a medical device manufactured by Mariner Endosurgery, Inc.. It received FDA 510(k) clearance on 2018-12-13 under approval number K182434. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LaparoGuard?

LaparoGuard is a medical device that received FDA 510(k) clearance on 2018-12-13. It is manufactured by Mariner Endosurgery, Inc.. The 510(k) number is K182434.

When was LaparoGuard approved by the FDA?

LaparoGuard received FDA 510(k) clearance on 2018-12-13, under approval number K182434.

What company makes LaparoGuard?

LaparoGuard is manufactured by Mariner Endosurgery, Inc..

What is the FDA product code for LaparoGuard?

The FDA product code for LaparoGuard is GCJ.

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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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