Zeta Navigation System (ZNS131-US)
K-Number: K251927 · 2025-10-10
ApplicantZeta Surgical, Inc.
Decision Date2025-10-10
Product CodeSGE
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Zeta Navigation System (ZNS131-US) is a medical device manufactured by Zeta Surgical, Inc.. It received FDA 510(k) clearance on 2025-10-10 under approval number K251927. The device is classified under product code SGE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Zeta Navigation System (ZNS131-US)?
Zeta Navigation System (ZNS131-US) is a medical device that received FDA 510(k) clearance on 2025-10-10. It is manufactured by Zeta Surgical, Inc.. The 510(k) number is K251927.
When was Zeta Navigation System (ZNS131-US) approved by the FDA?
Zeta Navigation System (ZNS131-US) received FDA 510(k) clearance on 2025-10-10, under approval number K251927.
What company makes Zeta Navigation System (ZNS131-US)?
Zeta Navigation System (ZNS131-US) is manufactured by Zeta Surgical, Inc..
What is the FDA product code for Zeta Navigation System (ZNS131-US)?
The FDA product code for Zeta Navigation System (ZNS131-US) is SGE.
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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.