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FDA 510(k)

SX-One MicroKnife

K-Number: K192873 · 2019-12-20

ApplicantSonex Health, Inc.
Decision Date2019-12-20
Product CodeLXH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SX-One MicroKnife is a medical device manufactured by Sonex Health, Inc.. It received FDA 510(k) clearance on 2019-12-20 under approval number K192873. The device is classified under product code LXH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SX-One MicroKnife?

SX-One MicroKnife is a medical device that received FDA 510(k) clearance on 2019-12-20. It is manufactured by Sonex Health, Inc.. The 510(k) number is K192873.

When was SX-One MicroKnife approved by the FDA?

SX-One MicroKnife received FDA 510(k) clearance on 2019-12-20, under approval number K192873.

What company makes SX-One MicroKnife?

SX-One MicroKnife is manufactured by Sonex Health, Inc..

What is the FDA product code for SX-One MicroKnife?

The FDA product code for SX-One MicroKnife is LXH.

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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