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FDA 510(k)

Intellitorq

K-Number: K180092 · 2018-03-08

ApplicantGauthier Biomedical, Inc.
Decision Date2018-03-08
Product CodeHXC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Intellitorq is a medical device manufactured by Gauthier Biomedical, Inc.. It received FDA 510(k) clearance on 2018-03-08 under approval number K180092. The device is classified under product code HXC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intellitorq?

Intellitorq is a medical device that received FDA 510(k) clearance on 2018-03-08. It is manufactured by Gauthier Biomedical, Inc.. The 510(k) number is K180092.

When was Intellitorq approved by the FDA?

Intellitorq received FDA 510(k) clearance on 2018-03-08, under approval number K180092.

What company makes Intellitorq?

Intellitorq is manufactured by Gauthier Biomedical, Inc..

What is the FDA product code for Intellitorq?

The FDA product code for Intellitorq is HXC.

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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