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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 the device name listed in this FDA 510(k) record. The listed applicant is Sonex Health, Inc.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) 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. The listed applicant is Sonex Health, Inc.. The 510(k) number is K192873.

When did SX-One MicroKnife receive FDA 510(k) clearance?

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

Who is the listed applicant for SX-One MicroKnife?

The FDA 510(k) record lists Sonex Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Sonex Health, Inc. 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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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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