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FDA 510(k)

g.Nautilus PRO

K-Number: K171669 · 2017-07-05

ApplicantG.Tec Medical Engineering GmbH
Decision Date2017-07-05
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

g.Nautilus 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 2017-07-05 under 510(k) number K171669. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the g.Nautilus PRO?

g.Nautilus PRO is a medical device that received FDA 510(k) clearance on 2017-07-05. The listed applicant is G.Tec Medical Engineering GmbH. The 510(k) number is K171669.

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

g.Nautilus PRO received FDA 510(k) clearance on 2017-07-05, under 510(k) number K171669.

Who is the listed applicant for g.Nautilus 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.Nautilus PRO?

The FDA product code for g.Nautilus PRO is GWL.

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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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Related Devices (Code: GWL)

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

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

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