FDA 510(k)

g.Estim FES

K-Number: K200088 · 2020-10-29

Decision Date2020-10-29

Product CodeIPF

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

g.Estim FES 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 2020-10-29 under 510(k) number K200088. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the g.Estim FES?

g.Estim FES is a medical device that received FDA 510(k) clearance on 2020-10-29. The listed applicant is G.Tec Medical Engineering GmbH. The 510(k) number is K200088.

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

g.Estim FES received FDA 510(k) clearance on 2020-10-29, under 510(k) number K200088.

Who is the listed applicant for g.Estim FES?

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 FES?

The FDA product code for g.Estim FES is IPF.

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.

K191432cortiQ PRO K173684g.Estim PRO K171669g.Nautilus PRO

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.