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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 a medical device manufactured by G.Tec Medical Engineering GmbH. It received FDA 510(k) clearance on 2017-07-05 under approval 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. It is manufactured by G.Tec Medical Engineering GmbH. The 510(k) number is K171669.

When was g.Nautilus PRO approved by the FDA?

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

What company makes g.Nautilus PRO?

g.Nautilus PRO is manufactured by G.Tec Medical Engineering GmbH.

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

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

Other Devices by G.Tec Medical Engineering GmbH

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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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