g.Estim PRO
K-Number: K173684 · 2018-05-04
ApplicantG.Tec Medical Engineering GmbH
Decision Date2018-05-04
Product CodeGYC
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
g.Estim PRO is a medical device manufactured by G.Tec Medical Engineering GmbH. It received FDA 510(k) clearance on 2018-05-04 under approval number K173684. The device is classified under product code GYC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the g.Estim PRO?
g.Estim PRO is a medical device that received FDA 510(k) clearance on 2018-05-04. It is manufactured by G.Tec Medical Engineering GmbH. The 510(k) number is K173684.
When was g.Estim PRO approved by the FDA?
g.Estim PRO received FDA 510(k) clearance on 2018-05-04, under approval number K173684.
What company makes g.Estim PRO?
g.Estim PRO is manufactured by G.Tec Medical Engineering GmbH.
What is the FDA product code for g.Estim PRO?
The FDA product code for g.Estim PRO is GYC.
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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.