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FDA 510(k)

Zeta Navigation System

K-Number: K253663 · 2026-05-01

ApplicantZeta Surgical, Inc.
Decision Date2026-05-01
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Zeta Navigation System is a medical device manufactured by Zeta Surgical, Inc.. It received FDA 510(k) clearance on 2026-05-01 under approval number K253663. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zeta Navigation System?

Zeta Navigation System is a medical device that received FDA 510(k) clearance on 2026-05-01. It is manufactured by Zeta Surgical, Inc.. The 510(k) number is K253663.

When was Zeta Navigation System approved by the FDA?

Zeta Navigation System received FDA 510(k) clearance on 2026-05-01, under approval number K253663.

What company makes Zeta Navigation System?

Zeta Navigation System is manufactured by Zeta Surgical, Inc..

What is the FDA product code for Zeta Navigation System?

The FDA product code for Zeta Navigation System is HAW.

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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