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FDA 510(k)

SimplCath

K-Number: K182511 · 2019-03-20

ApplicantF&S Medical Solutions, LLC
Decision Date2019-03-20
Product CodeGBM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SimplCath is a medical device manufactured by F&S Medical Solutions, LLC. It received FDA 510(k) clearance on 2019-03-20 under approval number K182511. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SimplCath?

SimplCath is a medical device that received FDA 510(k) clearance on 2019-03-20. It is manufactured by F&S Medical Solutions, LLC. The 510(k) number is K182511.

When was SimplCath approved by the FDA?

SimplCath received FDA 510(k) clearance on 2019-03-20, under approval number K182511.

What company makes SimplCath?

SimplCath is manufactured by F&S Medical Solutions, LLC.

What is the FDA product code for SimplCath?

The FDA product code for SimplCath is GBM.

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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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