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FDA 510(k)

SoundBite® Crossing System XS Peripheral

K-Number: K230159 · 2023-08-28

ApplicantSoundbite Medical Solutions, Inc.
Decision Date2023-08-28
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SoundBite® Crossing System XS Peripheral is a medical device manufactured by Soundbite Medical Solutions, Inc.. It received FDA 510(k) clearance on 2023-08-28 under approval number K230159. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SoundBite® Crossing System XS Peripheral?

SoundBite® Crossing System XS Peripheral is a medical device that received FDA 510(k) clearance on 2023-08-28. It is manufactured by Soundbite Medical Solutions, Inc.. The 510(k) number is K230159.

When was SoundBite® Crossing System XS Peripheral approved by the FDA?

SoundBite® Crossing System XS Peripheral received FDA 510(k) clearance on 2023-08-28, under approval number K230159.

What company makes SoundBite® Crossing System XS Peripheral?

SoundBite® Crossing System XS Peripheral is manufactured by Soundbite Medical Solutions, Inc..

What is the FDA product code for SoundBite® Crossing System XS Peripheral?

The FDA product code for SoundBite® Crossing System XS Peripheral is PDU.

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Related PubMed Literature

PMID: 40077817 Research Progress on Neural Cell Culture Systems. Current neuropharmacology (2025)

Other Devices by Soundbite Medical Solutions, Inc.

K210839SoundBite Crossing System - Peripheral (14P)

Related Devices (Code: PDU)

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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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