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FDA 510(k)

Soliton Acoustic Wave Device

K-Number: K190542 · 2019-05-24

ApplicantSoliton, Inc.
Decision Date2019-05-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Soliton Acoustic Wave Device is a medical device manufactured by Soliton, Inc.. It received FDA 510(k) clearance on 2019-05-24 under approval number K190542. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Soliton Acoustic Wave Device?

Soliton Acoustic Wave Device is a medical device that received FDA 510(k) clearance on 2019-05-24. It is manufactured by Soliton, Inc.. The 510(k) number is K190542.

When was Soliton Acoustic Wave Device approved by the FDA?

Soliton Acoustic Wave Device received FDA 510(k) clearance on 2019-05-24, under approval number K190542.

What company makes Soliton Acoustic Wave Device?

Soliton Acoustic Wave Device is manufactured by Soliton, Inc..

What is the FDA product code for Soliton Acoustic Wave Device?

The FDA product code for Soliton Acoustic Wave Device is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other Devices by Soliton, Inc.

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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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