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FDA 510(k)

New Wave System

K-Number: K260455 · 2026-03-13

ApplicantZeto, Inc.
Decision Date2026-03-13
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

New Wave System is a medical device manufactured by Zeto, Inc.. It received FDA 510(k) clearance on 2026-03-13 under approval number K260455. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the New Wave System?

New Wave System is a medical device that received FDA 510(k) clearance on 2026-03-13. It is manufactured by Zeto, Inc.. The 510(k) number is K260455.

When was New Wave System approved by the FDA?

New Wave System received FDA 510(k) clearance on 2026-03-13, under approval number K260455.

What company makes New Wave System?

New Wave System is manufactured by Zeto, Inc..

What is the FDA product code for New Wave System?

The FDA product code for New Wave System is GWQ.

Other Devices by Zeto, Inc.

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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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