FDA 510(k)

SimplCath

Numéro K : K182511 · 2019-03-20

Date de décision2019-03-20

Code produitGBM

Comité consultatifGU

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

What is the SimplCath?

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

When did SimplCath receive FDA 510(k) clearance?

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

Who is the listed applicant for SimplCath?

The FDA 510(k) record lists F&S Medical Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SimplCath?

The FDA product code for SimplCath is GBM.

Essais cliniques associés

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Dispositifs connexes (Code : GBM)

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Source officielle

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