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FDA 510(k)

Auxilock GFS Mini, GFS II Large, and GFS Ultimate

K-Number: K213018 · 2022-11-18

ApplicantAuxein Medical Private Limited
Decision Date2022-11-18
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Auxilock GFS Mini, GFS II Large, and GFS Ultimate is a medical device manufactured by Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-11-18 under approval number K213018. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Auxilock GFS Mini, GFS II Large, and GFS Ultimate?

Auxilock GFS Mini, GFS II Large, and GFS Ultimate is a medical device that received FDA 510(k) clearance on 2022-11-18. It is manufactured by Auxein Medical Private Limited. The 510(k) number is K213018.

When was Auxilock GFS Mini, GFS II Large, and GFS Ultimate approved by the FDA?

Auxilock GFS Mini, GFS II Large, and GFS Ultimate received FDA 510(k) clearance on 2022-11-18, under approval number K213018.

What company makes Auxilock GFS Mini, GFS II Large, and GFS Ultimate?

Auxilock GFS Mini, GFS II Large, and GFS Ultimate is manufactured by Auxein Medical Private Limited.

What is the FDA product code for Auxilock GFS Mini, GFS II Large, and GFS Ultimate?

The FDA product code for Auxilock GFS Mini, GFS II Large, and GFS Ultimate is MBI.

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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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