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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is G.Tec Medical Engineering GmbH. It received FDA 510(k) clearance on 2018-05-04 under 510(k) 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. The listed applicant is G.Tec Medical Engineering GmbH. The 510(k) number is K173684.

When did g.Estim PRO receive FDA 510(k) clearance?

g.Estim PRO received FDA 510(k) clearance on 2018-05-04, under 510(k) number K173684.

Who is the listed applicant for g.Estim PRO?

The FDA 510(k) record lists G.Tec Medical Engineering GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for g.Estim PRO?

The FDA product code for g.Estim PRO is GYC.

Other records listing G.Tec Medical Engineering GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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